Identity
- Trade Name
- Phantom® Fibula Nail System FDA UDI
- Generic Name
- Periosteal elevator, reusable FDA UDI
- Device Name
- Periosteal Elevator FDA UDI
- Model / Reference
- P99-150-2104 FDA UDI
- Description
- Periosteal Elevator FDA UDI
Identifiers
- Catalog Number
- P99-150-2104 FDA UDI
- Primary DI / UDI-DI
- 00889795134561 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Periosteal elevator, reusable 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
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
Category: Periosteal elevator, reusable
Phantom® Fibula Nail System by Paragon 28 — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Periosteal elevator, reusable.
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- BARRIER PLACEMENT INSTRUMENT — W.H. Holden, Inc. · Class I
- ELEVATOR — KLS-Martin L.P. · Class I
- HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
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 6b906916-ff16-4a52-a08a-6028ec68ba8b 34 fields · synced May 30, 2026