Identity
- Trade Name
- GPS FDA UDI
- Generic Name
- Orthopaedic intraoperative positioning pin, reusable FDA UDI
- Device Name
- THREADED PIN SIZE 1.2 COLLARED 2PK NONSTERILE FDA UDI
- Model / Reference
- 521-79-27 FDA UDI
- Description
- THREADED PIN SIZE 1.2 COLLARED 2PK NONSTERILE FDA UDI
Identifiers
- Catalog Number
- 521-79-27 FDA UDI
- Primary DI / UDI-DI
- 10885862280169 FDA UDI
- FDA Product Code
- HWE FDA UDI
- GMDN Term
- Orthopaedic intraoperative positioning pin, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Gps by Exactech, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Exactech, Inc.
Sources (1)
- FDA UDI a8895e27-4003-4408-ab6c-cdf3e940c1f4 36 fields · synced Jun 1, 2026