Identity
- Trade Name
- Half Blue X-ray Film WB FDA UDI
- Generic Name
- Medical x-ray film, screen FDA UDI
- Device Name
- 100SH 11X14IN HALF BLUE X-RAY FDA UDI
- Model / Reference
- Half Blue X-ray Film WB FDA UDI
- Description
- 100SH 11X14IN HALF BLUE X-RAY FDA UDI
Identifiers
- Catalog Number
- 1623867 FDA UDI
- Primary DI / UDI-DI
- 40889971623863 FDA UDI
- FDA Product Code
- IWZ FDA UDI
- GMDN Term
- Medical x-ray film, screen FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.1840 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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: Medical x-ray film, screen
Half Blue X-ray Film WB by Carestream Health, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medical x-ray film, screen.
- B Plus - Full Blue — Agfa Corp. · Class I
- M Plus - Half Blue — Agfa Corp. · Class I
- CP-BU M — Agfa Corp. · Class I
- SG-Regular Green — Agfa Corp. · Class I
- CP-BU M — Agfa Corp. · Class I
- SG-Regular Green — Agfa Corp. · Class I
- CP-BU M — Agfa Corp. · Class I
- CP-BU M — Agfa 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 ee7692c1-4de8-4183-8e96-dddf928ca2fa 35 fields · synced Jun 8, 2026