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Batrik Medical Manufacturing Inc.: FDA-registered device maker in Lachine Quebec, Canada, 1 510(k) clearance

Name: Batrik Medical Manufacturing Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Batrik Medical Manufacturing Inc. is registered with the FDA (registration 9681702) in Lachine Quebec, Canada. It lists 18 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 11, 1993. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9681702
FEI number: 3003749234
Address: 2165 46th Avenue, Lachine Quebec, Canada, H8T 2P1
Owner or operator: BATRIK MEDICAL MANUFACTURING INC. (9026328)
Roles: Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed: June 6, 1996
Registered through: 2026
Brand names listed: Batrik non surgical shoe covers, Bitestrong, Clamp Covers, Corner Pockets, Dry Endo Sponge, Face Shield, Coveralls & Chemo Coveralls, G.O.L.F.F. ABBREVIATION FOR, I.D. Roll/Sheet Tape and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Cleaning Brushes, For Endoscope	MNL	1	Contract manufacturer, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Accessory, Surgical Apparel	LYU	1	Repackager or relabeler	accessdata.fda.gov
Adaptor, Bulbs, Miscellaneous, For Endoscope	FFY	1	Repackager or relabeler	accessdata.fda.gov
Anti Fog Solution And Accessories, Endoscopy	OCT	2	Repackager or relabeler	accessdata.fda.gov
Cover, Shoe, Operating-Room	FXP	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Endoscopic Bite Block	MNK	1	Manufacturer	accessdata.fda.gov
Instrument, Ligature Passing And Knot Tying	HCF	1	Manufacturer	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Instrument, Surgical, Disposable	KDC	1	Contract manufacturer, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Marker, Skin	FZZ	1	Repackager or relabeler	accessdata.fda.gov
Non-Surgical Gown	OEA	1	Repackager or relabeler	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Manufacturer	accessdata.fda.gov
Pad, Eye	HMP	1	Repackager or relabeler	accessdata.fda.gov
Solvent, Adhesive Tape	KOX	1	Repackager or relabeler	accessdata.fda.gov
Stand, Infusion	FOX	1	Repackager or relabeler	accessdata.fda.gov
Stool, Operating-Room	FZM	1	Repackager or relabeler	accessdata.fda.gov
Tourniquet, Nonpneumatic	GAX	1	Repackager or relabeler	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Manufacturer, Repackager or relabeler	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
August 11, 1993	K932449	DR. FOG	OCT	Substantially Equivalent	O.R. Concepts, Inc.	accessdata.fda.gov

Compare with other makers

Updated August 11, 1993. 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.