FDA Registration
Active
🇺🇸 United States
Atlas Pro Driver Hex Collet (APD-CA-001-1)
Reg #: 2081135
·
FEI: 2081135
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- PRO-DEX, INC.
- Registration Number
- 2081135
- FEI Number
- 2081135
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2361 McGaw Avenue
- City
- Irvine
- State
- CA
- ZIP
- 92614
- Country
- US
Owner / Operator
- Firm Name
- PRO-DEX, INC.
- Operator Number
- 2081135
- Address
- 2361 McGaw Avenue, --
- City
- Irvine
- State
- CA
- Postal Code
- 92614
- Country
- US
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 | 2020-02-13 |
Proprietary Names
Atlas Pro Driver Hex Collet (APD-CA-001-1)
Atlas Pro Driver Battery Single Use Battery Case (APD-BP-010S-1)
Atlas Pro Driver (APD-1000-1)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device