Identity
- Trade Name
- Forearm Plating System FDA UDI
- Generic Name
- Manual orthopaedic bender, reusable FDA UDI
- Model / Reference
- Universal Bending Irons, 3.5mm FDA UDI
Identifiers
- Catalog Number
- UNV-BND-35 FDA UDI
- Primary DI / UDI-DI
- 00841506110011 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Manual orthopaedic bender, reusable 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Manual orthopaedic bender, reusable
Forearm Plating System by Skeletal Dynamics L.l.c. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Skeletal Dynamics L.l.c.
Sources (1)
- FDA UDI 0052b4df-c9bc-4adc-a1b3-f2b803a49b90 34 fields · synced Jun 1, 2026