Simpex Drill Bit DB-078-5
Simpex Drill Bit DB-078-5 is a Class I device made by Simpex Medical, Inc., listed in FDA GUDID since 18 Oct 2019 (UDI-DI B068DB07851), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB068DB07851 | Date18 Oct 2019 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Simpex Drill Bit
- Generic name
- Fluted surgical drill bit, single-use, non-sterile
- Model / Ref / Catalog
- DB-078-5
- Primary DI / UDI-DI
- B068DB07851
- FDA product code
- HTW
- GMDN term
- Fluted surgical drill bit, single-use, non-sterile
- Device class
- Class I
- Regulation number
- 888.4540
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
- Size
- Outer Diameter — 2.0 Millimeter
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