Identity
- Trade Name
- Bun-Yo-Matic™ Lapidus Clamp System FDA UDI
- Generic Name
- Orthopaedic implantation sleeve, reusable FDA UDI
- Device Name
- Lapidus Nail Tissue Protector, Rotated 90 FDA UDI
- Model / Reference
- P30-100-5310 FDA UDI
- Description
- Lapidus Nail Tissue Protector, Rotated 90 FDA UDI
Identifiers
- Catalog Number
- P30-100-5310 FDA UDI
- Primary DI / UDI-DI
- 00889795129413 FDA UDI
- FDA Product Code
- FZK FDA UDI
- GMDN Term
- Orthopaedic implantation sleeve, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4950 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Orthopaedic implantation sleeve, reusable
Bun-Yo-Matic™ Lapidus Clamp System by Paragon 28 — 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
- Paragon 28
Sources (1)
- FDA UDI e835d80f-dd39-459e-9254-e871916cec57 34 fields · synced Jun 6, 2026