Identity
- Trade Name
- Equinoxe FDA UDI
- Generic Name
- Intraoperative bone pin/screw, non-sterile FDA UDI
- Device Name
- 3.2MM K-WIRE, THD, SHORT 2 K-WIRES PER PACK FDA UDI
- Model / Reference
- 321-52-10 FDA UDI
- Description
- 3.2MM K-WIRE, THD, SHORT 2 K-WIRES PER PACK FDA UDI
Identifiers
- Catalog Number
- 321-52-10 FDA UDI
- Primary DI / UDI-DI
- 10885862580771 FDA UDI
- FDA Product Code
- HWE FDA UDI
- GMDN Term
- Intraoperative bone pin/screw, non-sterile FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 3.2 Millimeter FDA UDI
Category: Intraoperative bone pin/screw, non-sterile
Equinoxe by Exactech, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 0b35a8f9-2f80-4756-b72c-bd0c727bc131 35 fields · synced Jun 8, 2026