Identity
- Trade Name
- Elite FDA UDI
- Generic Name
- Orthopaedic bone staple, non-adjustable FDA UDI
- Device Name
- ELITE 20x15x7mm, Y-Shaped Bridge, 3 Legs FDA UDI
- Model / Reference
- EL-201507Y3 FDA UDI
- Description
- ELITE 20x15x7mm, Y-Shaped Bridge, 3 Legs FDA UDI
Identifiers
- Catalog Number
- EL201507Y3 FDA UDI
- Primary DI / UDI-DI
- 00810633021767 FDA UDI
- FDA Product Code
- JDR FDA UDI
- GMDN Term
- Orthopaedic bone staple, non-adjustable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Orthopaedic bone staple, non-adjustable
Elite by Synthes — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic bone staple, non-adjustable.
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- Arthrex® — Arthrex, Inc. · Class II
- JAWS Nitinol Staple System — Paragon 28 · Class II
- GEO Staple System — GRAMERCY EXTREMITY ORTHOPEDICS, LLC. · Class II
- CARINA — HNM TOTAL RECON 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 II | Pending data |
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Manufacturer
- Manufacturer
- Synthes
Sources (1)
- FDA UDI 625f5002-5e8e-41a5-b9fd-f6e8de315b9c 36 fields · synced May 31, 2026