Identity
- Trade Name
- FOREFOOT SOLUTIONS™ FDA UDI
- Generic Name
- Cannulated surgical drill bit, single-use FDA UDI
- Device Name
- The 2' in 1' cannulated shouldered drill, with a 6.0mm diameter tri shank attachment and a three lip 3mm diameter countersink, is designed to drill in one single drive the body of the 3.0 & 3.7mm compression screws and the shape of the screw heads to allow complete countersink. FDA UDI
- Model / Reference
- 119417ND FDA UDI
- Description
- The 2' in 1' cannulated shouldered drill, with a 6.0mm diameter tri shank attachment and a three lip 3mm diameter countersink, is designed to drill in one single drive the body of the 3.0 & 3.7mm compression screws and the shape of the screw heads to allow complete countersink. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10381780045281 FDA UDI
- FDA Product Code
- HTW FDA UDI
- GMDN Term
- Cannulated surgical drill bit, single-use 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
No
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
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: Cannulated surgical drill bit, single-use
Forefoot Solutions™ by Newdeal Sas — 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
- Newdeal Sas
Sources (1)
- FDA UDI b4fbf10e-1c7a-4667-a549-4af1b7479956 36 fields · synced May 31, 2026