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Steripack Medical Poland SP. Z O.O.: FDA-registered device maker in Jelcz-Laskowice Dolnoslaskie, Poland, 1 510(k) clearance

Name: Steripack Medical Poland SP. Z O.O. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Steripack Medical Poland SP. Z O.O. is registered with the FDA (registration 3007766601) in Jelcz-Laskowice Dolnoslaskie, Poland. It lists 20 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 25, 2001. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3007766601
Address: Leg, ul. Japonska 1, Jelcz-Laskowice Dolnoslaskie, Poland, 55-220
Owner or operator: SteriPack Medical Poland Sp. z o.o. (10029329)
Roles: Contract manufacturer, Manufacturer
First device listed: May 1, 2009
Registered through: 2026
Brand names listed: ARIA DILATOR 14.5MM NM, ARIA DILATOR 22.5MM, ARIA DILATOR 6.5MM, ARIA NM PROBE/GUIDE WIRE, BATTERY PACK 2 FOR QUIKDRIVE, BATTERY PACK FOR VariSpeed, Bit, Drill, DePuy Synthes Locking Screws for Medullary Nails, 4 and 5 mm and more

Devices it lists

Device	Product code	Class	Role	Source
Agent, Absorbable Hemostatic, Collagen Based	LMF	3	Contract manufacturer	accessdata.fda.gov
Applicator, Absorbent Tipped, Sterile	KXG	1	Contract manufacturer	accessdata.fda.gov
Bandage, Elastic	FQM	1	Contract manufacturer	accessdata.fda.gov
Bit, Drill	HTW	1	Contract manufacturer	accessdata.fda.gov
Blood Detection Capsule	QUD	2	Contract manufacturer	accessdata.fda.gov
Cable, Electrode	IKD	2	Contract manufacturer	accessdata.fda.gov
Device, Hemostasis, Vascular	MGB	3	Contract manufacturer	accessdata.fda.gov
Electrode, Needle	GXZ	2	Contract manufacturer	accessdata.fda.gov
Gastrointestinal Tubes With Enteral Specific Connectors	PIF	2	Contract manufacturer	accessdata.fda.gov
Guide, Needle, Surgical	GDF	1	Contract manufacturer	accessdata.fda.gov
Imager, Ultrasonic Obstetric-Gynecologic	HEM	2	Contract manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Lumbar	MAX	2	Contract manufacturer	accessdata.fda.gov
Labware, Assisted Reproduction	MQK	2	Contract manufacturer	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Contract manufacturer	accessdata.fda.gov
Motor, Surgical Instrument, Ac-Powered	GEY	1	Contract manufacturer	accessdata.fda.gov
Nail, Fixation, Bone	JDS	2	Contract manufacturer	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	Manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Contract manufacturer	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Contract manufacturer	accessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)	KNT	2	Contract 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
October 25, 2001	K012736	MONOJECT SAFETY NEEDLE	FMI	Substantially Equivalent	Tyco Healthcare	accessdata.fda.gov

Compare with other makers

Updated October 25, 2001. 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.