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Baby Gorilla®/Gorilla® Plating System
FDA UDIClass I (US FDA UDI)
by Paragon 28
Identity
- Trade Name
- Baby Gorilla®/Gorilla® Plating System FDA UDI
- Generic Name
- Bone tap, reusable FDA UDI
- Device Name
- Tap, Double Lead, 4.5mm FDA UDI
- Model / Reference
- P51-911-4500 FDA UDI
- Description
- Tap, Double Lead, 4.5mm FDA UDI
Identifiers
- Catalog Number
- P51-911-4500 FDA UDI
- Primary DI / UDI-DI
- 00889795053015 FDA UDI
- FDA Product Code
- HWX FDA UDI
- GMDN Term
- Bone tap, 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Bone tap, reusable
Baby Gorilla®/Gorilla® Plating System by Paragon 28 — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone tap, reusable.
- BIOSURE — Smith & Nephew, Inc. · Class I
- NobelActive® — Nobel Biocare AG · Class I
- CORTICAL TAP — Biomet Orthopedics, Inc. · Class I
- PressON™ — NEXUS SPINE, L.L.C. · Class I
- Insite — TORNIER, INC. · Class I
- ReLine — Nuvasive, Inc. · Class I
- Mariner MIS — SeaSpine Orthopedics Corporation · Class I
- Response 5.5/6.0 Spine System — ORTHOPEDIATRICS CORP. · 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 13d78a4e-1b7a-4f9c-b29d-38b980230a57 34 fields · synced May 30, 2026