CARESTREAM DRX-EVOLUTION Plus 8624249

GUDID 60889978624249

DRX-EVOLUTION PLUS SYSTEM L1741032

CARESTREAM HEALTH, INC.

Stationary basic diagnostic x-ray system, digital
Primary Device ID60889978624249
NIH Device Record Key03a58035-91d3-4f6f-8a81-efc0775007dc
Commercial Distribution StatusIn Commercial Distribution
Brand NameCARESTREAM DRX-EVOLUTION Plus
Version Model NumberCARESTREAM DRX-EVOLUTION Plus
Catalog Number8624249
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
GS160889978624249 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KPRSystem, x-ray, stationary

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-24
Device Publish Date2021-05-16

On-Brand Devices [CARESTREAM DRX-EVOLUTION Plus]

60889978624263DRX-EVOLUTION PLUS SYSTEM LOSHPD
60889978624256DRX-EVOLUTION PLUS SYSTEM L1741040
60889978624249DRX-EVOLUTION PLUS SYSTEM L1741032
60889978624218DRX-EVOLUTION PLUS SYSTEM L1739218
60889978624201DRX-EVOLUTION PLUS SYSTEM L1739192

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