Identity
- Trade Name
- GEO Staple System FDA UDI
- Generic Name
- Orthopaedic bone staple driver FDA UDI
- Device Name
- Staple Tamp, Large FDA UDI
- Model / Reference
- 24000002 FDA UDI
- Description
- Staple Tamp, Large FDA UDI
Identifiers
- Primary DI / UDI-DI
- B471240000020 FDA UDI
- FDA Product Code
- HXG FDA UDI
- GMDN Term
- Orthopaedic bone staple driver 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
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthopaedic bone staple driver
GEO Staple System by Gramercy Extremity Orthopedics, Llc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone staple driver.
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- DynaBridge — FUSION ORTHOPEDICS, LLC · Class II
- Orbitum Staple System — CPM Medical Consultants, LLC · Class II
- Orbitum Staple System — CPM Medical Consultants, LLC · Class II
- SOLUSTAPLE® — Newdeal Sas · 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
- Gramercy Extremity Orthopedics, Llc.
Sources (1)
- FDA UDI 0983e516-3385-4373-a7a6-98b69031db2e 35 fields · synced Jun 1, 2026