Identity
- Trade Name
- DIRECTVIEW CR Gridded Cassette with PQ Screen FDA UDI
- Generic Name
- Digital imaging cassette/phosphor plate FDA UDI
- Device Name
- DIRECTVIEW CR Grid Cass w PQ Scrn 35x43 FDA UDI
- Model / Reference
- DIRECTVIEW CR Gridded Cassette with PQ Screen FDA UDI
- Description
- DIRECTVIEW CR Grid Cass w PQ Scrn 35x43 FDA UDI
Identifiers
- Catalog Number
- 8637688 FDA UDI
- Primary DI / UDI-DI
- 40889978637689 FDA UDI
- FDA Product Code
- IXJ FDA UDI
- GMDN Term
- Digital imaging cassette/phosphor plate FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.1910 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
DIRECTVIEW CR Gridded Cassette with PQ Screen by Carestream Health, Inc. — 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
- Carestream Health, Inc.
Sources (1)
- FDA UDI 330302d6-3847-4b3c-abc0-4f3d998ff142 36 fields · synced Jun 6, 2026