Identity
- Trade Name
- Baby Gorilla/Gorilla Plating System FDA UDI
- Generic Name
- Bone hook FDA UDI
- Device Name
- P28 Bone Hook FDA UDI
- Model / Reference
- P99-150-0007 FDA UDI
- Description
- P28 Bone Hook FDA UDI
Identifiers
- Catalog Number
- P99-150-0007 FDA UDI
- Primary DI / UDI-DI
- 00889795019905 FDA UDI
- FDA Product Code
- KIK FDA UDI
- GMDN Term
- Bone hook FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Bone hook
Baby Gorilla/Gorilla Plating System by Paragon 28 — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Bone hook.
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- GELPI NEROMA RETRACTOR — SONTEC INSTRUMENTS, INC. · 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 e7bbe001-b58c-4ee4-b1be-e71dd378acff 34 fields · synced May 31, 2026