Identity
- Trade Name
- Wolf X-Ray FDA UDI
- Generic Name
- X-ray intensifying screen FDA UDI
- Device Name
- Intensifying Screen, Detail Speed, 10" X 12" FDA UDI
- Model / Reference
- 10005 FDA UDI
- Description
- Intensifying Screen, Detail Speed, 10" X 12" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843696119577 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
Wolf X-Ray by Flow X-Ray Corp. — 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
- Flow X-Ray Corp.
Sources (1)
- FDA UDI 920f98fe-5eb4-43c8-9bee-04429bd9fc72 33 fields · synced May 30, 2026