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Small Bone Phantom Intramedullary Nail System
FDA UDIClass I (US FDA UDI)
by Paragon 28
Identity
- Trade Name
- Small Bone Phantom Intramedullary Nail System FDA UDI
- Generic Name
- Orthopaedic bone wire FDA UDI
- Device Name
- Lapidus Nail, Targeting Guide Olive Wire, Threaded, 1.8mm FDA UDI
- Model / Reference
- P99-251-1607 FDA UDI
- Description
- Lapidus Nail, Targeting Guide Olive Wire, Threaded, 1.8mm FDA UDI
Identifiers
- Catalog Number
- P99-251-1607 FDA UDI
- Primary DI / UDI-DI
- 00889795041586 FDA UDI
- FDA Product Code
- HXI FDA UDI
- GMDN Term
- Orthopaedic bone wire 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Orthopaedic bone wire
Small Bone Phantom Intramedullary Nail 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 e3d9b61b-1093-425f-8676-bce99075fe85 34 fields · synced May 30, 2026