Identity
- Trade Name
- Scheker Prosthesis FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- Locking Drill Guide 2.5mm FDA UDI
- Model / Reference
- DRUJ-LDG25 FDA UDI
- Description
- Locking Drill Guide 2.5mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- B013DRUJLDG250 FDA UDI
- FDA Product Code
- FZX FDA UDI
- GMDN Term
- Surgical drill guide, reusable 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
No
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 Prosthesis 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 ffce8f5a-d9e3-409c-aeff-dc83f2c0dcec 35 fields · synced Jun 1, 2026