Value Systems 8621666

GUDID 60889978621668

GENERATOR GRP D 50KW 3P 208-240 VAC

CARESTREAM HEALTH, INC.

Stationary basic diagnostic x-ray system, digital
Primary Device ID60889978621668
NIH Device Record Key7ed095f1-94c6-47de-8f53-aca3e7f71eb4
Commercial Distribution StatusIn Commercial Distribution
Brand NameValue Systems
Version Model NumberValue Systems
Catalog Number8621666
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS160889978621668 [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 Date2020-10-05
Device Publish Date2020-09-26

On-Brand Devices [Value Systems]

60889978621668GENERATOR GRP D 50KW 3P 208-240 VAC
60889978621651GENERATOR GRP C 50KW 3P 380-480 VAC
60889976701539GENERATOR GRP C 65KW 3P 380-480 VAC
60889976701522GENERATOR GRP C 80KW 3P 380-480 VAC

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