Ortho CP-GU M

FDA UDI

Class I (US FDA UDI)

by Agfa Corp.

Identity

Trade Name: Ortho CP-GU M FDA UDI
Generic Name: Medical x-ray film, screen FDA UDI
Model / Reference: ORTHO CP-GU M 28x35 FDA UDI

Identifiers

Catalog Number: 55BWR FDA UDI
Primary DI / UDI-DI: 05414904198100 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: Width — 35 Centimeter FDA UDI
Length — 28 Centimeter FDA UDI

Category: Medical x-ray film, screen

Ortho CP-GU M by Agfa 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: Agfa Corp.

Sources (1)

FDA UDI 87e64471-0637-4025-b113-5d9e52313718 36 fields · synced May 30, 2026