Identity
- Trade Name
- FOREFOOT SOLUTIONS™ FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- The drilling guide is used to guide the drills while preparing the holes for the staples. After having decided which interaxis between the two legs of the staple, the guide is ajusted and the holes are drilled.The joint should be in the middle between the two sleeves of the guide. FDA UDI
- Model / Reference
- 119301ND FDA UDI
- Description
- The drilling guide is used to guide the drills while preparing the holes for the staples. After having decided which interaxis between the two legs of the staple, the guide is ajusted and the holes are drilled.The joint should be in the middle between the two sleeves of the guide. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10381780045267 FDA UDI
- FDA Product Code
- FZX FDA UDI
- GMDN Term
- Surgical drill guide, reusable 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical drill guide, reusable
Forefoot Solutions™ by Newdeal Sas — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Hintermann Series — Dt Medtech, LLC · 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
- Newdeal Sas
Sources (1)
- FDA UDI c9502659-1f55-47ea-b61e-26d929c2bc97 36 fields · synced Jun 8, 2026