FDA Registration
Active
🇺🇸 United States
Cannulated Headed Reamer
Reg #: 1064017
·
FEI: 3000190635
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- AME INT'L.
- Registration Number
- 1064017
- FEI Number
- 3000190635
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 7440 SOUTH WEST 50 TERR., No. 108
- City
- MIAMI
- State
- FL
- ZIP
- 33155
- Country
- US
Owner / Operator
- Firm Name
- AME INT'L.
- Operator Number
- 9036247
- Address
- 7440 SOUTH WEST 50 TERR., #108, --
- City
- Miami
- State
- FL
- Postal Code
- 33155
- Country
- US
- Correspondent
- VICTOR - FERNANDEZ
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2013-12-13 |
Proprietary Names
Cannulated Headed Reamer
Cannulated Drill
2.8mm, 3mm, 3.2mm, 4mm Reusable Drill Bits
2.8mm, 3mm, 3.2mm, 4mm Sterile Drill Bits
2.8mm, 3mm, 3.2mm, 4mm Unsterile Drill Bits
Establishment Types
Repack or Relabel Medical Device