Oncology EDR2 Film 1161769

GUDID 60889971161765

ONCO EDR2 FILM 35X43-14X17 RDYPK 50SH

CARESTREAM HEALTH, INC.

Medical x-ray film, non-screen Medical x-ray film, non-screen
Primary Device ID60889971161765
NIH Device Record Key63de261b-0e40-45cb-aaa9-b2f315ad6c34
Commercial Distribution StatusIn Commercial Distribution
Brand NameOncology EDR2 Film
Version Model NumberOncology EDR2 Film
Catalog Number1161769
Company DUNS793169512
Company NameCARESTREAM HEALTH, INC.
Device Count50
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100889971161763 [Unit of Use]
GS140889971161761 [Primary]
GS160889971161765 [Package]
Contains: 40889971161761
Package: Case [2 Units]
In Commercial Distribution

FDA Product Code

IWZFilm, radiographic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-05-13
Device Publish Date2016-09-16

On-Brand Devices [Oncology EDR2 Film]

60889978097210Oncology EDR2 Film 10X12in RDYPK 50SH
60889971161765ONCO EDR2 FILM 35X43-14X17 RDYPK 50SH

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.