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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
- Orthopaedic implantation sleeve, reusable FDA UDI
- Device Name
- Gorilla R3CON, Drill Guide, 2.7 Threaded, Locking, SS, Long FDA UDI
- Model / Reference
- P51-900-1004 FDA UDI
- Description
- Gorilla R3CON, Drill Guide, 2.7 Threaded, Locking, SS, Long FDA UDI
Identifiers
- Catalog Number
- P51-900-1004 FDA UDI
- Primary DI / UDI-DI
- 00889795099723 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic implantation sleeve, 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
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Orthopaedic implantation sleeve, 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 Orthopaedic implantation sleeve, reusable.
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- Salvo® Spine System — Spine Wave, Inc. · Class I
- DRILL SLEEVE — Biomet Orthopedics, 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 fc84a2a2-839b-495a-912b-77a316b88158 34 fields · synced Jun 8, 2026