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Zeramex XT Surgery Tray, fully equipped, without drills
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Zeramex XT Surgery Tray, fully equipped, without drills FDA UDI
- Generic Name
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- Tools FDA UDI
- Model / Reference
- XT48865 FDA UDI
- Description
- Tools FDA UDI
Identifiers
- Catalog Number
- XT48865 FDA UDI
- Primary DI / UDI-DI
- 07640161392823 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
- 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
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
Zeramex XT Surgery Tray, fully equipped, without drills by CeramTec Schweiz GmbH — 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
- CeramTec Schweiz GmbH
Sources (1)
- FDA UDI 2a053d56-8c8c-4b21-a377-7ffa3592f44c 37 fields · synced May 30, 2026