Identity
- Trade Name
- UNI-CP Compression Plate FDA UDI
- Generic Name
- Implantable bone washer FDA UDI
- Device Name
- STAINLESS STEEL LOCK SCREW FOR DIA. 3.5MM SCREW FDA UDI
- Model / Reference
- 186300ND FDA UDI
- Description
- STAINLESS STEEL LOCK SCREW FOR DIA. 3.5MM SCREW FDA UDI
Identifiers
- Catalog Number
- 186300ND FDA UDI
- Primary DI / UDI-DI
- 00885556910245 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Implantable bone washer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Implantable bone washer
UNI-CP Compression Plate by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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K070447 also covers:
K091609 also covers:
K093163 also covers:
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- Integra® Total Wrist Fusion System — Ascension Orthopedics, Inc.
- Integra® Total Wrist Fusion System — Ascension Orthopedics, Inc.
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI be61fc05-6c5a-4b29-a5b1-bedbf462b224 37 fields · synced Jun 8, 2026