INNOVA

GUDID 00840682147378

GE MEDICAL SYSTEMS

Stationary angiographic x-ray system, digital
Primary Device ID00840682147378
NIH Device Record Key0a1c4781-8bca-49e7-92d0-2541427418c7
Commercial Distribution StatusIn Commercial Distribution
Brand NameINNOVA
Version Model NumberIGS 3 001
Company DUNS266062561
Company NameGE MEDICAL SYSTEMS
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(999)999-9999
Email[email protected]

Device Identifiers

Device Issuing AgencyDevice ID
GS100840682147378 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OWBInterventional fluoroscopic x-ray system

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-11
Device Publish Date2020-02-03

On-Brand Devices [INNOVA]

00840682121637UPG X100 001
00840682147378IGS 3 001

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