IMAGE1 H3-LINK

GUDID 04048551356517

CCU,MODULAR,H3-LINK,US

Karl Storz GmbH & Co. KG

Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit
Primary Device ID04048551356517
NIH Device Record Keyec53b54c-1740-4709-9721-1209ae690d81
Commercial Distribution StatusIn Commercial Distribution
Brand NameIMAGE1 H3-LINK
Version Model NumberTC300US
Company DUNS315731430
Company NameKarl Storz GmbH & Co. KG
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-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104048551356517 [Primary]
GS104048551356517 [Primary]
GS104048551356517 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FETEndoscopic video imaging system/component, gastroenterology-urology
FETEndoscopic video imaging system/component, gastroenterology-urology
FETEndoscopic video imaging system/component, gastroenterology-urology

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-05-19
Device Publish Date2016-09-23

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