B Plus - Full Blue

FDA UDI

Class I (US FDA UDI)

by Agfa Corp.

Identity

Trade Name: B Plus - Full Blue FDA UDI
Generic Name: Medical x-ray film, screen FDA UDI
Model / Reference: B PLUS-FULL BLUE 35x92 FDA UDI

Identifiers

Catalog Number: EKYB8 FDA UDI
Primary DI / UDI-DI: 05414904031728 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 35 Centimeter FDA UDI
Width — 92 Centimeter FDA UDI

Category: Medical x-ray film, screen

B Plus - Full Blue by Agfa Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 c891f00d-7904-4070-aa47-0268fad4acec 36 fields · synced May 30, 2026