Identity
- Trade Name
- SURFIX® FDA UDI
- Generic Name
- Fluted surgical drill bit, single-use FDA UDI
- Device Name
- The drill of diameter 3.5 mm and of total length 195 mm with AO attachment is used to drill the bone to prepare the implantation of the screws. FDA UDI
- Model / Reference
- MA008ND FDA UDI
- Description
- The drill of diameter 3.5 mm and of total length 195 mm with AO attachment is used to drill the bone to prepare the implantation of the screws. FDA UDI
Identifiers
- Catalog Number
- MA008ND FDA UDI
- Primary DI / UDI-DI
- 10381780043263 FDA UDI
- FDA Product Code
- HTW FDA UDI
- GMDN Term
- Fluted 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: Fluted surgical drill bit, single-use
Surfix® 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 ebdcf4ad-38d2-4e13-8234-0427a18cd80f 37 fields · synced Jun 8, 2026