FDA Registration
Active
🇺🇸 United States
1.8MM./2.4MM COMBI DRILL GD.
Reg #: 1833986
·
FEI: 1000139987
·
Expires 2025
Products
1
Proprietary Names
13
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 |
|---|---|---|---|---|---|
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2018-11-08 |
Proprietary Names
1.8MM./2.4MM COMBI DRILL GD.
MTP SCR TARGETING GUIDE RIGHT
MTP SCR TARGETING GUIDE LEFT
LEFT LAPIDUS SCREW TARGETING GUIDE
Micro 1.6mm VA Handheld Drill Guide
Micro 2mm Overdrill Drill Tube
RIGHT LAPIDUS SCREW TARGETING GUIDE
Wire Guide for Targetting Guide
Mini 2mm VA Handheld Drill Guide
Small 3.5mm Overdrill Drill Tube
Small 2mm VA Handheld Drill Guide
Mini 2.5mm Overdrill Drill Tube
Small 2.7mm VA Handheld Drill Guide
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)