Half Blue X-ray Film WB 1605385

GUDID 60889971605382

100SH 18X43-7X17 HALF BLUE X-RAY

CARESTREAM HEALTH, INC.

Medical x-ray film, screen Medical x-ray film, screen
Primary Device ID60889971605382
NIH Device Record Key7a3ce79a-2fb2-4bf6-b6b5-df63e680853c
Commercial Distribution Discontinuation2019-04-30
Commercial Distribution StatusNot in Commercial Distribution
Brand NameHalf Blue X-ray Film WB
Version Model NumberHalf Blue X-ray Film WB
Catalog Number1605385
Company DUNS793169512
Company NameCARESTREAM HEALTH, INC.
Device Count100
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

Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100889971605380 [Unit of Use]
GS140889971605388 [Primary]
GS160889971605382 [Package]
Contains: 40889971605388
Package: Case [5 Units]
Discontinued: 2019-04-30
Not 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 Date2019-05-03
Device Publish Date2016-09-16

On-Brand Devices [Half Blue X-ray Film WB]

60889971623867100SH 11X14IN HALF BLUE X-RAY
60889971605382100SH 18X43-7X17 HALF BLUE X-RAY
60889971545749100SH 24X30CM HALF BLUE X-RAY
60889971246363100SH 35X43-14X17 HALF BLUE X-RAY
6088997120519325SH 14X36IN HALF BLUE X-RAY
60889971118349100SH 10X12IN HALF BLUE X-RAY
60889971088673100SH 8X10IN HALF BLUE X-RAY

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