FDA Registration
Active
🇨🇦 Canada
BATRIK MEDICAL MANUFACTURING INC.
Reg #: 9681702
·
FEI: 3003749234
·
Expires 2026
Products
18
Proprietary Names
30
Establishment Types
3
Classifications
18
Registration Details
- Registration Name
- BATRIK MEDICAL MANUFACTURING INC.
- Registration Number
- 9681702
- FEI Number
- 3003749234
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2165 46th Avenue
- City
- Lachine Quebec
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K932449
Owner / Operator
- Firm Name
- BATRIK MEDICAL MANUFACTURING INC.
- Operator Number
- 9026328
- Address
- 2165 46e Avenue, --
- City
- Lachine
- State
- Quebec
- Postal Code
- H8T 2P1
- Country
- CA
- Correspondent
- Suzy C Bairos
US Agent
- Business Name
- Tobias Systems LLC
- Contact Name
- Katie Doane
- Address
- 15815 Sw 11th Court Rd
- City
- Ocala
- State
- FL
- ZIP
- 34473
- Country
- US
- [email protected]
- Phone
- 716 7750533
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Endoscopic Bite Block | MNK | Class 1 | Gastroenterology, Urology | No | 2008-03-26 |
| Instrument, Ligature Passing And Knot Tying | HCF | Class 1 | General, Plastic Surgery | No | 1996-06-06 |
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 2023-10-04 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2020-07-16 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-06-30 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 1996-06-06 |
| Stool, Operating-Room | FZM | Class 1 | General, Plastic Surgery | No | 2019-12-04 |
| Marker, Skin | FZZ | Class 1 | General, Plastic Surgery | No | 2007-03-12 |
| Pad, Eye | HMP | Class 1 | General, Plastic Surgery | No | 2024-11-12 |
| Adaptor, Bulbs, Miscellaneous, For Endoscope | FFY | Class 1 | Gastroenterology, Urology | No | 2019-12-04 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2007-03-12 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2009-09-25 |
| Anti Fog Solution And Accessories, Endoscopy | OCT | Class 2 | Gastroenterology, Urology | No | 2007-03-30 |
| Solvent, Adhesive Tape | KOX | Class 1 | General, Plastic Surgery | No | 1996-06-06 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2010-10-27 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2009-10-05 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2008-03-26 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 2009-10-05 |
Proprietary Names
Bitestrong
Vascular Silicone Ties
Clamp Covers
IV poles
Batrik non surgical shoe covers
SafeFace Level 1 & 2 Isolation Gowns & Chemo Gowns-non-surgical
Pin Mat
Transport Bags for endoscopes & Instruments
Stacking Step Stools
SKINS
PandaPatch Adhesive Eye Protector
Valve Covers Couvrette
Tourniquet
Magnes-Mat
Scrub Pads
Corner Pockets
Padlocks
I.D. Roll/Sheet Tape
Instrument Protectors
G.O.L.F.F. ABBREVIATION FOR
Tape-B-Gone
Face Shield, Coveralls & Chemo Coveralls
Pin Kaps
IN-BRUSH
Dry Endo Sponge
Your First check F1rst Wipe
Your First check PrAmLi enzymatic sponges
Your First check PrAmLi enzymatic spray & detergents
Non-Sterile Cautery Tip Cleaner
Suture Clamp Tags
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)