Vita Flex CR System 6579346

GUDID 60889976579343

VITA FLEX CR SYSTEM 60PPH WITH PC&MONITO

CARESTREAM HEALTH, INC.

Computed radiography digital imaging scanner
Primary Device ID60889976579343
NIH Device Record Keyf848b535-2981-4f94-9c09-a07902ca0006
Commercial Distribution StatusIn Commercial Distribution
Brand NameVita Flex CR System
Version Model NumberVita Flex CR System
Catalog Number6579346
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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS160889976579343 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQBSolid state x-ray imager (flat panel/digital imager)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-07-25
Device Publish Date2019-08-03

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60889971069443UPGRADE Vita Flex 30 to 45 PPH
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60889971069405NB Vita Flex CR 30PPH solution PC/Monito
60889971069382Vita Flex CR 45PPH solution PC/Monitor
60889971069375Vita Flex CR 30PPH solution PC/Monitor
60889971069306Vita Flex CR System 45PPH
60889971067241Vita Flex CR System 30PPH
60889976579367VITA FLEX CR SYSTEM, NB 60PPH WITH PC&MO
60889976579343VITA FLEX CR SYSTEM 60PPH WITH PC&MONITO
60889976579336VITA FLEX CR SYSTEM 60PPH

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