Identity
- Trade Name
- M Plus - Half Blue FDA UDI
- Generic Name
- Medical x-ray film, screen FDA UDI
- Model / Reference
- M PLUS - HALF BLUE 20x25 FDA UDI
Identifiers
- Catalog Number
- 3XA3C FDA UDI
- Primary DI / UDI-DI
- 05414904028575 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 20 Centimeter FDA UDIWidth — 25 Centimeter FDA UDI
Category: Medical x-ray film, screen
M Plus - Half Blue by Agfa Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medical x-ray film, screen.
- Medical X-ray Cassette with Green 400 Screens — CARESTREAM HEALTH, INC. · Class II
- Half Blue X-ray Film WB — CARESTREAM HEALTH, INC. · Class I
- Medical X-ray Blue / MXBE Film — CARESTREAM HEALTH, INC. · Class I
- E Blue X-ray Film WB — CARESTREAM HEALTH, INC. · Class I
- Medical X-ray Green / MXG Film — CARESTREAM HEALTH, INC. · Class I
- T-MAT G/RA Film — CARESTREAM HEALTH, INC. · Class I
- Medical X-ray Blue / MXB Film — CARESTREAM HEALTH, INC. · Class I
- X-SIGHT G/RA Film — CARESTREAM HEALTH, INC. · 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
- Agfa Corp.
Sources (1)
- FDA UDI e8fb8949-1a13-424e-852d-73c825c13e0d 36 fields · synced Jun 1, 2026