FDA Registration
Active
🇺🇸 United States
Drill 1.9MM
Reg #: 1833986
·
FEI: 1000139987
·
Expires 2025
Products
1
Proprietary Names
35
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 |
|---|---|---|---|---|---|
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2012-12-26 |
Proprietary Names
Drill 1.9MM
HERBERT pilot drill 2
QC DRL BIT. 2.7MM DIA 125MM
QC DRL BIT. 1.5MM DIA 110MM
QC DRL BIT. 3.2MM DIA 195MM
STR S DRL BIT 2.7MM DIA 12.7CM
STR S DRL BIT 2.5MM DIA 12.7CM
QC DRL BIT. 1.5MM DIA 85MM
QC DRL BIT. 2MM DIA 125MM
QC DRL BIT. 2.7MM DIA 100MM
Q/C DRILL 5MMDIAX195MM LONG
QC DRL BIT. 2.5MM DIA 125MM
CANN MAIN DRILL 3.1MM DIA
2MM CANNULATED DRILL W/QUICK COUPLING, 150MM
HERB BONE SCR PILOT POW DRILL 3.2MM DIA
STR S DRL BIT 3.5MM DIA 12.7CM
CANN PILOT DRILL 3.8MM DIA
STR S DRL BIT 4.5MM DIA 12.7CM
DRILL 1.5MM DIA
QC DRL BIT. 4.5MM DIA 145MM
QC DRL BIT. 4.5MM DIA 195MM
STR S DRL BIT 2MM DIA 12.7CM
QC DRL BIT. 1.1MM DIA 60MM
Q/C DRILL 2.5MM DIA XLNG
CANN PILOT DRILL 5.5MM DIA
CANN MAIN DRILL 4.6MM DIA
QC DRL BIT. 3.5MM DIA 110MM
CANNULATED DRILL, 6MM
CANNULATED DRILL, 9MM
CANNULATED DRILL, 5MM
CANNULATED DRILL, 7MM
CANNULATED DRILL, 10MM
CANNULATED DRILL, 11MM
CANNULATED DRILL, 8MM
CANNULATED DRILL, 4MM
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)