Carestream DRX-1 System

FDA UDI

Class II (US FDA UDI)

by Carestream Health, Inc.

Identity

Trade Name: Carestream DRX-1 System FDA UDI
Generic Name: Indirect flat panel x-ray detector FDA UDI
Device Name: DRX-1 SYSTEM CONSOLE UPGRADE FDA UDI
Model / Reference: Carestream DRX-1 System FDA UDI
Description: DRX-1 SYSTEM CONSOLE UPGRADE FDA UDI

Identifiers

Catalog Number: 8625923 FDA UDI
Primary DI / UDI-DI: 60889978625925 FDA UDI
FDA Product Code: MQB FDA UDI
GMDN Term: Indirect flat panel x-ray detector FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1680 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

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Indirect flat panel x-ray detector

Carestream DRX-1 System by Carestream Health, Inc. — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Carestream Health, Inc.

Sources (1)

FDA UDI e6e88fa2-5657-4d3b-bf52-2486576285bf 34 fields · synced Jun 8, 2026