INSIGHT VHC Thoracic Screens 8678922

GUDID 60889978678921

PR 35X35CM INSGHT VHC SCREEN C1

CARESTREAM HEALTH, INC.

X-ray intensifying screen
Primary Device ID60889978678921
NIH Device Record Key8d3ac30f-8780-4090-b296-8fff1b0e91f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameINSIGHT VHC Thoracic Screens
Version Model NumberINSIGHT VHC Thoracic Screens
Catalog Number8678922
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

Device Identifiers

Device Issuing AgencyDevice ID
GS160889978678921 [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 Number2
Public Version Date2018-03-29
Device Publish Date2016-09-16

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