DIRECTVIEW CR Long-Length Cassette with PQ Screen 8010035

GUDID 60889978010035

DV CR LONG-LENGTH CASS PKG W/ PQ

CARESTREAM HEALTH, INC.

Digital imaging cassette/storage phosphor screen
Primary Device ID60889978010035
NIH Device Record Key165a160e-3421-4fe2-8cfd-eeb3f07d6826
Commercial Distribution StatusIn Commercial Distribution
Brand NameDIRECTVIEW CR Long-Length Cassette with PQ Screen
Version Model NumberDIRECTVIEW CR Long-Length Cassette with PQ Screen
Catalog Number8010035
Company DUNS793169512
Company NameCARESTREAM HEALTH, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS160889978010035 [Primary]

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 Number3
Public Version Date2019-01-14
Device Publish Date2016-09-16

On-Brand Devices [DIRECTVIEW CR Long-Length Cassette with PQ Screen]

60889978754144CR LONG LENGTH PORTABLE CASS W/PQ
60889978010035DV CR LONG-LENGTH CASS PKG W/ PQ
60889971033574CR LLI W/PQ SCREEN

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