Identity
- Trade Name
- Karl Schumacher FDA UDI
- Generic Name
- Dental elevator, tooth/root FDA UDI
- Device Name
- Winter X-Bar #13L, Left Cryer, X-Lg FDA UDI
- Model / Reference
- ELX0013L FDA UDI
- Description
- Winter X-Bar #13L, Left Cryer, X-Lg FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00842517108561 FDA UDI
- FDA Product Code
- EMJ FDA UDI
- GMDN Term
- Dental elevator, tooth/root FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 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
Karl Schumacher by Karl Schumacher Dental, 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
- Karl Schumacher Dental, Llc
Sources (1)
- FDA UDI d845a85a-79f7-4c49-90e9-6e6a8ee788ff 35 fields · synced May 30, 2026