FDA Registration
Active
🇺🇸 United States
2MM RDB MED, ZIM 5091-260
Reg #: 1833986
·
FEI: 1000139987
·
Expires 2025
Products
1
Proprietary Names
29
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 |
|---|---|---|---|---|---|
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2012-12-17 |
Proprietary Names
2MM RDB MED, ZIM 5091-260
2MM CANNULATED DRILL W/QUICK COUPLING, 150MM
4.5MM CANNULATED DRILL BIT/QC
3.2MM CANNULATED DRILL BIT/QC
2MM CANNULATED DRILL BIT/QC
5.5MM OC BUR MED, ZIM 5091-238
4MM RDB MED, ZIM 5091-264
1.5MM TSCSCB MED,ZIM 5091-202
7MM ST DERM MED, ZIM 5091-81
RD SOLID CARB BUR LONG (2MM)
3MM SPP MED, ZIM 5091-243
5120-10-100 W/ 11MM HEAD
SWANSON PILOT POINT BURS MED
4MM ST DERM MED, ZIM 5091-80
6.5MM RSC BUR MED,ZIM 5091-232
4MM OV DD MED, ZIM 5091-270
1.5MM RSCB MED, ZIM 5091-222
2MM SPP MED, ZIM 5091-242
2.7MM CANNULATED DRILL BIT/QC
5120-12-160 W/8MM DIA
2MM RSC BUR MED,ZIM 5091-224
2.4MM RSC BUR MED,ZIM 5091-225
3MM NUERO BUR, EXTENDED
6MM RDB MED, ZIM 5091-268
10MM TP DERM MED,ZIM 5091-83
2MM TSCSCB MED,ZIM 5091-206
5MM RSCB XL, ZIM 5093-230
2MM LTSCSCB MED,ZIM 5091-214
4MM OC BUR XL, ZIM 5093-236
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)