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Oncology EDR2 Film

FDA UDI

Class I (US FDA UDI)

by Carestream Health, Inc.

Identity

Trade Name
Oncology EDR2 Film FDA UDI
Generic Name
Medical x-ray film, non-screen FDA UDI
Device Name
ONCO EDR2 FILM 35X43-14X17 RDYPK 50SH FDA UDI
Model / Reference
Oncology EDR2 Film FDA UDI
Description
ONCO EDR2 FILM 35X43-14X17 RDYPK 50SH FDA UDI

Identifiers

Catalog Number
1161769 FDA UDI
Primary DI / UDI-DI
40889971161761 FDA UDI
FDA Product Code
IWZ FDA UDI
GMDN Term
Medical x-ray film, non-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, non-screen

Oncology EDR2 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, non-screen.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Carestream Health, Inc.

Sources (1)

  • FDA UDI 63de261b-0e40-45cb-aaa9-b2f315ad6c34 35 fields · synced Jun 8, 2026