Identity
- Trade Name
- GEO Staple System FDA UDI
- Generic Name
- Orthopaedic bone staple, non-adjustable FDA UDI
- Device Name
- Staple 20mmx20mmx20mm, Symmetric Smooth Leg, Nitinol FDA UDI
- Model / Reference
- 14020200 FDA UDI
- Description
- Staple 20mmx20mmx20mm, Symmetric Smooth Leg, Nitinol FDA UDI
Identifiers
- Primary DI / UDI-DI
- B471140202000 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Width — 20 Millimeter FDA UDI
Category: Orthopaedic bone staple, non-adjustable
GEO Staple System by Gramercy Extremity Orthopedics, Llc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone staple, non-adjustable.
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- Elite — Synthes · Class II
- MotoBAND™ CP DynaForce® MTP — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
- Arthrex® — Arthrex, Inc. · Class II
- Speed Arc — Synthes · Class II
- JAWS Nitinol Staple System — Paragon 28 · 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
- Gramercy Extremity Orthopedics, Llc.
Sources (1)
- FDA UDI dc313bdb-4309-463c-8107-116543af06bb 36 fields · synced May 30, 2026