Identity
- Trade Name
- Oxboro™ Pin Cover FDA UDI
- Generic Name
- Needle guard FDA UDI
- Device Name
- Single use device intended to cover exposed ends of orthopedic pin and k-wires to help protect the exposed wire from snagging on clothing. FDA UDI
- Model / Reference
- 101000PBX FDA UDI
- Description
- Single use device intended to cover exposed ends of orthopedic pin and k-wires to help protect the exposed wire from snagging on clothing. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840113221066 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Needle guard FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Needle guard
Oxboro™ Pin Cover by Aspen Surgical Products, 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
- Aspen Surgical Products, Inc.
Sources (1)
- FDA UDI 17d36885-6cf5-460a-859a-6d44421167eb 34 fields · synced Jun 9, 2026