Identity
- Trade Name
- Cassette 35cmx43cm(IP 35cmx43cm)Kit FDA UDI
- Generic Name
- X-ray film cassette, manual FDA UDI
- Device Name
- The Cassette 35cmx43cm(IP 35cmx43cm)Kit is acquired X-ray images. and Transfer the image to your computer through the FireCR Flash. FDA UDI
- Model / Reference
- CA04 FDA UDI
- Description
- The Cassette 35cmx43cm(IP 35cmx43cm)Kit is acquired X-ray images. and Transfer the image to your computer through the FireCR Flash. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809466040429 FDA UDI
- FDA Product Code
- MQB FDA UDI
- GMDN Term
- X-ray film cassette, manual FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1680 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Width — 35 Centimeter FDA UDILength — 43 Centimeter FDA UDIWeight — 1.9 Kilogram FDA UDI
Category: X-ray film cassette, manual
Cassette 35cmx43cm(IP 35cmx43cm)Kit by DIGIRAY Corp. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- DIGIRAY Corp.
Sources (1)
- FDA UDI db1f545a-04a3-4c40-91b4-a4c731c7d0e2 35 fields · synced Jun 8, 2026