Identity
- Trade Name
- Scheker DRUJ FDA UDI
- Generic Name
- Orthopaedic guidewire, single-use FDA UDI
- Device Name
- Guide Wire/ Ulna Prep Pointed FDA UDI
- Model / Reference
- DRUJ-K100P FDA UDI
- Description
- Guide Wire/ Ulna Prep Pointed FDA UDI
Identifiers
- Catalog Number
- DRUJ-K100P FDA UDI
- Primary DI / UDI-DI
- B013DRUJK100P0 FDA UDI
- FDA Product Code
- FZX FDA UDI
- GMDN Term
- Orthopaedic guidewire, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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 5c2fef21-8d9a-47f1-b27e-4a28c964ee6b 35 fields · synced May 31, 2026