Identity
- Trade Name
- Baby Gorilla/Gorilla Plating System FDA UDI
- Generic Name
- Orthopaedic surgery tissue debris collector, reusable FDA UDI
- Device Name
- Morselizing Bone Graft Harvester, Door, 12mm FDA UDI
- Model / Reference
- P99-930-2010 FDA UDI
- Description
- Morselizing Bone Graft Harvester, Door, 12mm FDA UDI
Identifiers
- Catalog Number
- P99-930-2010 FDA UDI
- Primary DI / UDI-DI
- 00889795051851 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic surgery tissue debris collector, 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
No
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: Orthopaedic surgery tissue debris collector, reusable
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 Orthopaedic surgery tissue debris collector, reusable.
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- BIRMINGHAM HIP — Smith & Nephew, Inc. · Class III
- BIRMINGHAM HIP RESURFACING (BHR) — Smith & Nephew, Inc. · Class III
- BIRMINGHAM HIP RESURFACING (BHR) — Smith & Nephew, Inc. · Class III
- BIRMINGHAM HIP — Smith & Nephew, Inc. · Class III
- BIRMINGHAM HIP RESURFACING (BHR) — Smith & Nephew, Inc. · Class III
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 db064fed-853a-45b8-b7b2-604f3f74cd6c 34 fields · synced May 30, 2026