Value Systems 6701536

GUDID 60889976701539

GENERATOR GRP C 65KW 3P 380-480 VAC

CARESTREAM HEALTH, INC.

Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital
Primary Device ID60889976701539
NIH Device Record Keya3446b08-1e38-48ca-b9fc-7159a503aa0a
Commercial Distribution StatusIn Commercial Distribution
Brand NameValue Systems
Version Model NumberValue Systems
Catalog Number6701536
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-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS160889976701539 [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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