Identity
- Trade Name
- MEDENTiKA FDA UDI
- Generic Name
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- Surgical tray FDA UDI
- Model / Reference
- 0-13-97 FDA UDI
- Description
- Surgical tray FDA UDI
Identifiers
- Catalog Number
- 0-13-97 FDA UDI
- Primary DI / UDI-DI
- 04251574840769 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 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
Yes
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Dental/maxillofacial surgical procedure kit, non-medicated, reusable
MEDENTiKA by Medentika GmbH — 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
- Medentika GmbH
Sources (1)
- FDA UDI 47d8148d-2846-451c-839c-4835a3cb999c 36 fields · synced Jun 6, 2026