Data / Medical devices / United States / Trinity Sterile, Inc.
Trinity Sterile, Inc.: FDA-registered device maker in Salisbury, MD, United States, 8 510(k) clearances
Trinity Sterile, Inc. is registered with the FDA (registration 1123010) in Salisbury, MD, United States. It lists 79 device types. The FDA files 8 510(k) clearances under its listings, the newest dated December 6, 2018. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1123010
- FEI number
- 1000123297
- Address
- 201 Kiley Dr, Salisbury, MD, United States, 21801
- Owner or operator
- TRINITY STERILE, INC. (9003800)
- Roles
- Contract manufacturer, Contract sterilizer, Manufacturer, Repackager or relabeler
- First device listed
- June 5, 1992
- Registered through
- 2026
- Brand names listed
- AMS-623TG-6LF, AMS-744CP, AMS-823CP, AMS-872CP-1, AMS-905CS-1, Aspirator, Bandage, Biopsy Punch and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Accessories, Catheter | KGZ | 1 | Manufacturer | accessdata.fda.gov |
| Accessories, Cleaning Brushes, For Endoscope | MNL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Aspiration Tray | OJT | 1 | Manufacturer | accessdata.fda.gov |
| Bandage, Elastic | FQM | 1 | Manufacturer | accessdata.fda.gov |
| Bedding, Disposable, Medical | KME | 1 | Repackager or relabeler | accessdata.fda.gov |
| Blade, Scalpel | GES | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cannula, Ear | JYC | 1 | Manufacturer | accessdata.fda.gov |
| Catheter And Tip, Suction | JOL | 2 | Manufacturer | accessdata.fda.gov |
| Catheters, Suction, Tracheobronchial | BSY | 1 | Manufacturer | accessdata.fda.gov |
| Clamp, Circumcision | HFX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Clamp, Penile | FHA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Clamp, Surgical, General & Plastic Surgery | GDJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Curette, Ear | JYG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Curette, Surgical, General Use | FZS | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cutter, Surgical | FZT | 1 | Repackager or relabeler | accessdata.fda.gov |
| Drape, Surgical, Antimicrobial | KKX | 2 | Manufacturer | accessdata.fda.gov |
| Dressing Change Tray | OXQ | 1 | Contract manufacturer, Contract sterilizer, Manufacturer | accessdata.fda.gov |
| Elevator, Surgical, Dental | EMJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Endoscopic Bite Block | MNK | 1 | Manufacturer | accessdata.fda.gov |
| Explorer, Operative | EKB | 1 | Repackager or relabeler | accessdata.fda.gov |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | N | Repackager or relabeler | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 1 | Manufacturer | accessdata.fda.gov |
| File, Bone, Surgical | EMI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps | HTD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps, Ent | KAE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps, General & Plastic Surgery | GEN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps, Obstetrical | HDA | 2 | Repackager or relabeler | accessdata.fda.gov |
| Fork, Tuning | GWX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Formalin-Saline | IGC | 1 | Manufacturer | accessdata.fda.gov |
| General Surgery Tray | LRO | 2 | Manufacturer | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Handle, Scalpel | GDZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Holder, Needle; Orthopedic | HXK | 1 | Repackager or relabeler | accessdata.fda.gov |
| Hook, Microsurgical Ear | JYL | 1 | Repackager or relabeler | accessdata.fda.gov |
| I.V. Start Kit | LRS | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Ent Manual Surgical | LRC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instruments, Surgical, Cardiovascular | DWS | 1 | Repackager or relabeler | accessdata.fda.gov |
| Kit, Surgical Instrument, Disposable | KDD | 1 | Manufacturer | accessdata.fda.gov |
| Laceration Tray | PKD | 1 | Manufacturer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Ligator, Hemorrhoidal | FHN | 2 | Repackager or relabeler | accessdata.fda.gov |
| Mirror, Mouth | EAX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Mouthpiece, Saliva Ejector | DYN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Pessary, Vaginal | HHW | 2 | Repackager or relabeler | accessdata.fda.gov |
| Phlebotomy Blood Collection Kit | OFM | 2 | Manufacturer | accessdata.fda.gov |
| Plier, Orthodontic | JEX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Probe, Lachrymal | HNL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Punch, Biopsy, Surgical | EME | 1 | Manufacturer | accessdata.fda.gov |
| Punch, Surgical | LRY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Retractor | GAD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Ring Cutter | FNS | 1 | Repackager or relabeler | accessdata.fda.gov |
| Rongeur | HTX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Saw, Manual And Accessories | GDR | 1 | Repackager or relabeler | accessdata.fda.gov |
| Scalpel, One-Piece | GDX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Scissors, General, Surgical | LRW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Screw, Oral | KBW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Sound, Urethral, Metal Or Plastic | FBX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Sound, Uterine | HHM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Spatula, Ophthalmic | HND | 1 | Repackager or relabeler | accessdata.fda.gov |
| Spatula, Surgical, General & Plastic Surgery | GAF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Speculum, Rectal | FFQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Speculum, Vaginal, Metal | HDF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Speculum, Vaginal, Nonmetal | HIB | 2 | Repackager or relabeler | accessdata.fda.gov |
| Splint, Hand, And Components | ILH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Staple, Removable (Skin) | GDT | 1 | Manufacturer | accessdata.fda.gov |
| Suture Removal Kit | MCZ | 1 | Manufacturer | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Manufacturer | accessdata.fda.gov |
| Tenaculum, Uterine, Exempt | PUA | 2 | Manufacturer | accessdata.fda.gov |
| Tourniquet, Nonpneumatic | GAX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tracheotomy Care Kit | NXA | 2 | Manufacturer | accessdata.fda.gov |
| Tray, Biopsy, Without Biopsy Instruments | FCH | 1 | Manufacturer | accessdata.fda.gov |
| Tray, Surgical | LRP | 1 | Manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Manufacturer | accessdata.fda.gov |
| Urinary Drainage Collection Kit, For Indwelling Catheter | FCN | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|
| December 6, 2018 | K173048 | No-contact Forehead Thermometer | FLL | Substantially Equivalent | Dongguan Simzo Electronic Technology Co., Ltd. | accessdata.fda.gov |
| July 22, 2010 | K092981 | PANPAC VAGINAL PESSARY | HHW | Substantially Equivalent | Panpac Medical Corporation | accessdata.fda.gov |
| January 22, 2004 | K033403 | T.S. MEDICAL CIRCUMCISION CLAMP | HFX | Substantially Equivalent | T.S. Medical | accessdata.fda.gov |
| April 21, 1998 | K974382 | ACKERMANN SURGICAL INSTRUMENTS | GCJ | Substantially Equivalent | Ackermann Instrumente GmbH | accessdata.fda.gov |
| June 28, 1993 | K923361 | I.V. START KIT, STERILE, DISPOSABLE | LRS | Unknown | Trinity Laboratories, Inc. | accessdata.fda.gov |
| August 13, 1992 | K921394 | DRESSING CHANGE TRAY, STERILE, DISPOSABLE | KKX | Unknown | Trinity Laboratories, Inc. | accessdata.fda.gov |
| August 13, 1992 | K921204 | DELUXE WOUND CLOSURE TRAY, STERILE, DISPOSABLE | KKX | Unknown | Trinity Laboratories, Inc. | accessdata.fda.gov |
| May 11, 1992 | K920517 | MINOR LACERATION TRAY W/ INSTRUMENT, STERILE, DISP | KKX | Unknown | Trinity Laboratories, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|
| December 13, 2024 | 96068 | Class II | Ongoing | Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model/Catalog Number: IM46062 Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600022, 66 cases | Potential for hole in package compromising sterility of the medical kit. | accessdata.fda.gov |
| June 29, 2022 | 90625 | Class II | Terminated | Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708 | Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy | accessdata.fda.gov |
| February 23, 2021 | 87538 | Class II | Terminated | Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing). Product Number: TRIO0000l | Evidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility | accessdata.fda.gov |
Compare with other makers
Updated January 22, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.