Identity
- Trade Name
- GEO-Desis FDA UDI
- Generic Name
- Osteotomy guide, single-use FDA UDI
- Device Name
- Cut Guide, GEO-Desis, 2.5mm, Single Slot FDA UDI
- Model / Reference
- 29300025 FDA UDI
- Description
- Cut Guide, GEO-Desis, 2.5mm, Single Slot FDA UDI
Identifiers
- Primary DI / UDI-DI
- B471293000250 FDA UDI
- FDA Product Code
- HTZ FDA UDI
- GMDN Term
- Osteotomy guide, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Osteotomy guide, single-use
GEO-Desis by Gramercy Extremity Orthopedics, Llc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 a2782352-8eb6-46bb-86bb-018b98384c54 35 fields · synced May 30, 2026