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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 bone wire FDA UDI
- Device Name
- K Wires, 2.3, 100mm, 67.5mm notched FDA UDI
- Model / Reference
- P51-912-2310 FDA UDI
- Description
- K Wires, 2.3, 100mm, 67.5mm notched FDA UDI
Identifiers
- Catalog Number
- P51-912-2310 FDA UDI
- Primary DI / UDI-DI
- 00889795124418 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic bone wire
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 bone wire.
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- SMOOTH K-WIRE, DOUBLE END TROCAR POINT — Biomet Orthopedics, Inc. · Class II
- mahe medical GmbH — mahe medical gmbh · Class II
- OIC Variable Angle Small Fragment Locking Plate System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
- THP™ Hip Fracture Plating System — Biomet Orthopedics, Inc. · Class II
- gSource — GSOURCE, LLC. · Class II
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 cac06ac8-0e1c-4b86-bbde-9598da24c89b 34 fields · synced Jun 1, 2026