Identity
- Trade Name
- X-OMATIC Regular Screens FDA UDI
- Generic Name
- X-ray intensifying screen FDA UDI
- Device Name
- X-OMATIC Regular SCR, 1PR 5x12in NF FDA UDI
- Model / Reference
- X-OMATIC Regular Screens FDA UDI
- Description
- X-OMATIC Regular SCR, 1PR 5x12in NF FDA UDI
Identifiers
- Catalog Number
- 1820885 FDA UDI
- Primary DI / UDI-DI
- 60889971820884 FDA UDI
- FDA Product Code
- EAM FDA UDI
- GMDN Term
- X-ray intensifying screen FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.1960 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: X-ray intensifying screen
X-OMATIC Regular Screens by Carestream Health, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as X-ray intensifying screen.
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- Wolf X-Ray — Flow X-Ray Corp. · Class I
- Wolf X-Ray — Flow X-Ray Corp. · Class I
- Wolf X-Ray — Flow X-Ray Corp. · Class I
- Wolf X-Ray — Flow X-Ray Corp. · Class I
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 0df4f936-d454-4793-ab8b-797fb8dc4527 35 fields · synced Jun 8, 2026