DRGEM

GUDID 08800011121150

110-120V~ / 125kV

DRGEM Corporation

Stationary basic diagnostic x-ray system, analogue
Primary Device ID08800011121150
NIH Device Record Key549bf176-e3ac-41ca-abc2-6519441eec5d
Commercial Distribution StatusIn Commercial Distribution
Brand NameDRGEM
Version Model NumberSGXR-C52S
Company DUNS688477319
Company NameDRGEM Corporation
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 Datetrue
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
GS108800011121150 [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 Date2019-10-10
Device Publish Date2019-10-02

On-Brand Devices [DRGEM]

08800011103149100-240VAC, 150VA
08800011150037100~240V/150kV
08800011150020100~240V/125kV
08800011150013100~240V/150kV
08800011150006100~240V/125kV
08800011130008Digital Imaging Software
08800011140069220-230V~ / 150kV
08800011140052220-230V~ / 125kV
08800011140045220-230V~ / 150kV
08800011140038220-230V~ / 125kV
08800011121228100-240V~ / 150kV
08800011121211100-240V~ / 125kV
08800011121204100-240V~ / 150kV
08800011121198100-240V~ / 125kV
08800011121181220-230V~ / 150kV
08800011121174220-230V~ / 125kV
08800011121167110-120V~ / 150kV
08800011121150110-120V~ / 125kV
08800011121143220-230V~ / 150kV
08800011121136220-230V~ / 125kV
08800011121129110-120V~ / 150kV
08800011121112110-120V~ / 125kV
08800011121105220-230V~ / 150kV
08800011121099220-230V~ / 125kV
08800011121082110-120V~ / 150kV
08800011121075110-120V~ / 125kV
08800011121068480V3~ / 150kV
08800011121051400V3~ / 150kV
08800011121044380V3~ / 150kV
08800011121037480V3~ / 150kV
08800011121020400V3~ / 150kV
08800011121013380V3~ / 150kV
08800011121006480V3~ / 150kV
08800011120993400V3~ / 150kV
08800011120986380V3~ / 150kV
08800011120979480V3~ / 150kV
08800011120962480V3~ / 125kV
08800011120955400V3~ / 150kV
08800011120948400V3~ / 125kV
08800011120931380V3~ / 150kV
08800011120924380V3~ / 125kV
08800011120917220-230V~ / 150kV
08800011120900220-230V~ / 125kV
08800011120894480V3~ / 150kV
08800011120887480V3~ / 125kV
08800011120870380V3~ / 150kV
08800011120863380V3~ / 125kV
08800011120856400V3~ / 150kV
08800011120849400V3~ / 125kV
08800011120832220-230V~ / 150kV
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