Identity
- Trade Name
- Scheker DRUJ FDA UDI
- Generic Name
- Bone tap, single-use FDA UDI
- Device Name
- 3.5mm Quick Connect Tap FDA UDI
- Model / Reference
- DRUJ-T35 FDA UDI
- Description
- 3.5mm Quick Connect Tap FDA UDI
Identifiers
- Catalog Number
- DRUJ-T35 FDA UDI
- Primary DI / UDI-DI
- B013DRUJT350 FDA UDI
- FDA Product Code
- HWX FDA UDI
- GMDN Term
- Bone tap, single-use 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 |
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Manufacturer
- Manufacturer
- Aptis Medical, Llc.
Sources (1)
- FDA UDI c9e33f76-be40-49e1-bc41-610b7112f709 35 fields · synced May 30, 2026