Flexible Phosphor Screen GP-2 8271066

GUDID 60889978271061

Flexible Phosphor Scrn GP-2 25x30/10x12

CARESTREAM HEALTH, INC.

Digital imaging storage phosphor screen
Primary Device ID60889978271061
NIH Device Record Keyc7a8c199-f90b-4643-a370-7bc68817fbdd
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlexible Phosphor Screen GP-2
Version Model NumberFlexible Phosphor Screen GP-2
Catalog Number8271066
Company DUNS793169512
Company NameCARESTREAM HEALTH, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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 10 Degrees Celsius and 24 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS140889978271067 [Primary]
GS160889978271061 [Package]
Contains: 40889978271067
Package: Case [10 Units]
In Commercial Distribution

FDA Product Code

EAMScreen, intensifying, radiographic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-16

On-Brand Devices [Flexible Phosphor Screen GP-2]

60889978546350Flexible Phosphor Scrn GP-2 28x35/11x14
60889978376230FLEXIBLE PHOSPHOR SCREEN GP-2 20X25/8X10
60889971522436Flexible Phosphor Screen GP-2 15x30 cm
60889978271061Flexible Phosphor Scrn GP-2 25x30/10x12
60889978145423FLEXIBLE PHOSPHOR SCREEN GP-2 24X30 CM
60889971423160Flexible Phosphor Scrn GP-2 35x43/14x17
60889978979547FLEXIBLE PHOSPHOR SCRN GP-2 35X35/14X14

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