Digital Expert Access

GUDID 00195278263919

DE Modality Connectivity Executable

WIPRO GE HEALTHCARE PRIVATE LIMITED

Diagnostic x-ray digital imaging system workstation
Primary Device ID00195278263919
NIH Device Record Key8852431d-c1bb-443a-b6dd-145fdf329fa8
Commercial Distribution StatusIn Commercial Distribution
Brand NameDigital Expert Access
Version Model Number1
Company DUNS650140403
Company NameWIPRO GE HEALTHCARE PRIVATE LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
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
GS100195278263919 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, image processing, radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-15
Device Publish Date2021-04-07

Devices Manufactured by WIPRO GE HEALTHCARE PRIVATE LIMITED

00840682142724 - TRANSDUCER BELT - BUTTON - SINGLE PATIENT USE - 10 BOX2022-12-14 TRANSDUCER BELT - BUTTON - SINGLE PATIENT USE - 10 BOX
00195278263919 - Digital Expert Access2021-04-15DE Modality Connectivity Executable
00195278263919 - Digital Expert Access2021-04-15 DE Modality Connectivity Executable
00840682116992 - Mini Telemetry System2019-12-10
00840682117012 - Mini Telemetry System2019-12-10
00840682117067 - Mini Telemetry System2019-12-10
00840682117128 - Mini Telemetry System2019-12-10
00840682117166 - Mini Telemetry System2019-12-10
00840682143240 - Coro - Round MECG cable AHA2019-08-16

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