Identity
- Trade Name
- Karl Schumacher FDA UDI
- Generic Name
- Manual dental scaler, reusable FDA UDI
- Device Name
- Patina SR-N5 Lingual Stain Scaler FDA UDI
- Model / Reference
- SCA6001 FDA UDI
- Description
- Patina SR-N5 Lingual Stain Scaler FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00842517115859 FDA UDI
- FDA Product Code
- ELA FDA UDI
- GMDN Term
- Manual dental scaler, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- 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
Category: Manual dental scaler, reusable
Karl Schumacher by Karl Schumacher Dental, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Karl Schumacher Dental, Llc
Sources (1)
- FDA UDI de334a30-97c2-4b10-8e55-9f663cb387cd 34 fields · synced Jun 8, 2026