Identity
- Trade Name
- Scheker DRUJ FDA UDI
- Generic Name
- Fluted surgical drill bit, reusable FDA UDI
- Device Name
- 2.5mm Quick Connect Drill Bit FDA UDI
- Model / Reference
- DRUJ-B25 FDA UDI
- Description
- 2.5mm Quick Connect Drill Bit FDA UDI
Identifiers
- Catalog Number
- DRUJ-B25 FDA UDI
- Primary DI / UDI-DI
- B013DRUJB250 FDA UDI
- FDA Product Code
- HTW FDA UDI
- GMDN Term
- Fluted surgical drill bit, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- Not 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
No
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Scheker DRUJ by Aptis Medical, Llc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Aptis Medical, Llc.
Sources (1)
- FDA UDI 9973318c-c562-4a98-91d4-ac4717c55537 35 fields · synced May 30, 2026