Identity
- Trade Name
- Medical X-ray Blue / MXBE Film FDA UDI
- Generic Name
- Medical x-ray film, screen FDA UDI
- Device Name
- Medl X-ray Blue/MXBE Film 13X18cm 100SH FDA UDI
- Model / Reference
- Medical X-ray Blue / MXBE Film FDA UDI
- Description
- Medl X-ray Blue/MXBE Film 13X18cm 100SH FDA UDI
Identifiers
- Catalog Number
- 7711468 FDA UDI
- Primary DI / UDI-DI
- 40889977711465 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
Medical X-ray Blue / MXBE Film 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Carestream Health, Inc.
Sources (1)
- FDA UDI 79615da6-0e2f-4550-9de0-c7b004022219 35 fields · synced Jun 8, 2026