Identity
- Trade Name
- SURFIX® FDA UDI
- Generic Name
- Fluted surgical drill bit, single-use FDA UDI
- Device Name
- The drill of diameter 2.7 mm and of total length 125 mm with AO attachment is used to pre-drill before the insertion of the screw. Using a drilling guide, the screw length can be read from the calibrated scale on the drill. FDA UDI
- Model / Reference
- 219535ND FDA UDI
- Description
- The drill of diameter 2.7 mm and of total length 125 mm with AO attachment is used to pre-drill before the insertion of the screw. Using a drilling guide, the screw length can be read from the calibrated scale on the drill. FDA UDI
Identifiers
- Catalog Number
- 219535ND FDA UDI
- Primary DI / UDI-DI
- 10381780045465 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
Similar devices
Also classified as Fluted surgical drill bit, single-use.
- LEVEL ONE — KLS-Martin L.P. · Class I
- T2 ALPHA — Stryker Corp. · Class I
- Piccolo Composite Plate System — CARBOFIX ORTHOPEDICS LTD · Class II
- Nobel Biocare® — Nobel Biocare AG · Class I
- INSTRUMENT — Howmedica Osteonics Corp. · Class I
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class I
- EVOS — Smith & Nephew, Inc. · Class I
- EBA ONE — Citieffe · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Newdeal Sas
Sources (1)
- FDA UDI d5cc9f96-fa40-46a4-9bcd-f25402dd8a4d 37 fields · synced May 30, 2026