EndoNaut (Standalone) SW

GUDID 03760262480022

THERENVA

Radiology DICOM image processing application software
Primary Device ID03760262480022
NIH Device Record Key5336f161-d74f-46fb-83bb-d959ac61919d
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndoNaut (Standalone) SW
Version Model Number1.2
Company DUNS296780716
Company NameTHERENVA
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 Numberfalse
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
GS103760262480022 [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 Date2023-12-19
Device Publish Date2023-12-11

Devices Manufactured by THERENVA

03760262480022 - EndoNaut (Standalone) SW2023-12-19
03760262480022 - EndoNaut (Standalone) SW2023-12-19
03760262480015 - EndoSize2019-10-07

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