FDA Registration
Active
🇺🇸 United States
LARGE SCREWDRIVER JAWS
Reg #: 1833986
·
FEI: 1000139987
·
Expires 2025
Products
1
Proprietary Names
11
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- PRECISION EDGE SURGICAL PRODUCTS COMPANY
- Registration Number
- 1833986
- FEI Number
- 1000139987
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 415 W 12th Ave
- City
- Sault Sainte Marie
- State
- MI
- ZIP
- 49783
- Country
- US
Owner / Operator
- Firm Name
- Precision Edge Surgical Products Company
- Operator Number
- 10042577
- Address
- 415 West 12th Avenue
- City
- Sault Sainte Marie
- State
- MI
- Postal Code
- 49783
- Country
- US
- Correspondent
- Angela Gorsuch
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2018-11-08 |
Proprietary Names
LARGE SCREWDRIVER JAWS
Hex Driver (5mm/8mm)
Long Screw Hex Driver
Short Screw Hex Driver(3.5mm)
Long Screw driver with retention hex (3.5mm)
Long Removal and Insertion Hex
Short Screw Driver with Retention (3.5mm)
Instr, Bone Screw Screwdriver, TX25
Cannulated T6 Driver
Instr, 2mm Hex Driver Cannulated
Instr, H10 Driver Cannulated
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)