Data / Medical devices / United States / Entrotech Life Sciences, LLC
Entrotech Life Sciences, LLC: FDA-registered device maker in Columbus, OH, United States, 1 510(k) clearance
Entrotech Life Sciences, LLC is registered with the FDA (registration 3009134884) in Columbus, OH, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 7, 2014. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3009134884
- FEI number
- 3011393407
- Address
- 1245 Kinnear Road, Columbus, OH, United States, 43212
- Owner or operator
- entrotech life sciences, llc (10088716)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer
- First device listed
- October 4, 2023
- Registered through
- 2027
- Brand names listed
- Battle Wrap, Multi-T 2021KB, Multi-T 2021KS, PrevahexCHX 1483CH, PrevahexCHX 1484CH, PrevahexCHX 1485CH, PrevahexCHX 1491CH, PrevahexCHX 1492CH and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Compression | MHW | 1 | Contract manufacturer | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Contract manufacturer | accessdata.fda.gov |
| Tourniquet, Nonpneumatic | GAX | 1 | Complaint file establishment, Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| November 7, 2014 | K140389 | CHLORADERM ANTIMICROBIAL TRANSPARENT THIN FILM DRESSING, 2 3/8 X 2 3/4, 4 X 4 3/4 | FRO | Substantially Equivalent | Entrotech Life Sciences, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Dressing, Wound, Occlusive
- All makers of Tourniquet, Nonpneumatic
- All makers of Dressing, Wound, Drug
- All makers of Dressing, Compression
Updated November 7, 2014. 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.