FDA Device Establishments · JSON-LD · Markdown
FEI 2081135 · Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active
| FEI Number | 2081135 |
|---|---|
| Owner / Operator | PRO-DEX, INC. (#2081135) |
| Address | 2361 McGaw Avenue, Irvine, CA, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | GEY |
| Regulation § (21 CFR) | 878.4820 |
| Proprietary names | Pro-Dex Surgical Driver (PDSD-5000-X); PDCMF Power Driver (PDCMF-1000-X); Atlas Pro Driver Hex Collet (APD-CA-001-1); Atlas Pro Driver (APD-1000-1); Atlas Pro Driver Battery Single Use Battery Case (APD-BP-010S-1); Pro-Dex Surgical Driver, Single Pouch Battery Pack (PDBP-001-X; PDBP-010-X; PDBD-040-X) |
Source: openFDA. Public-domain (CC0).