Identity
- Trade Name
- Cefla FDA UDI
- Generic Name
- Dental x-ray film holder, reusable FDA UDI
- Device Name
- X-Ray sensor holder Refill Pack Posterior Size 1, Content: 5x posterior Upper Left / Lower Right - UDI 08717228441554 5x posterior Upper Right / Lower Left - UDI 08717228441561 FDA UDI
- Model / Reference
- CEF2011 FDA UDI
- Description
- X-Ray sensor holder Refill Pack Posterior Size 1, Content: 5x posterior Upper Left / Lower Right - UDI 08717228441554 5x posterior Upper Right / Lower Left - UDI 08717228441561 FDA UDI
Identifiers
- Catalog Number
- 97901106 FDA UDI
- Primary DI / UDI-DI
- 08717228440304 FDA UDI
- FDA Product Code
- EGZ FDA UDI
- GMDN Term
- Dental x-ray film holder, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.1905 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
Yes
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: Dental x-ray film holder, reusable
Cefla by DuPhaMed B.V. — 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
- DuPhaMed B.V.
Sources (1)
- FDA UDI 0dd738ce-00f9-4234-9354-bef65765efdd 34 fields · synced May 30, 2026