IMAGE1 X-LINK

GUDID 04048551356562

CCU,MODULAR,X-LINK,US

Karl Storz GmbH & Co. KG

Endoscopic video image processing unit
Primary Device ID04048551356562
NIH Device Record Keyd0c0a4e9-a1c2-4f90-bd29-c2e29b5b66ad
Commercial Distribution StatusIn Commercial Distribution
Brand NameIMAGE1 X-LINK
Version Model NumberTC301US
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

Customer Support Contacts

Phone+14242188201
Emailregulatory@karlstorz.com
Phone+14242188201
Emailregulatory@karlstorz.com
Phone+14242188201
Emailregulatory@karlstorz.com
Phone+14242188201
Emailregulatory@karlstorz.com
Phone+14242188201
Emailregulatory@karlstorz.com
Phone+14242188201
Emailregulatory@karlstorz.com
Phone+14242188201
Emailregulatory@karlstorz.com
Phone+14242188201
Emailregulatory@karlstorz.com
Phone+14242188201
Emailregulatory@karlstorz.com
Phone+14242188201
Emailregulatory@karlstorz.com
Phone+14242188201
Emailregulatory@karlstorz.com
Phone+14242188201
Emailregulatory@karlstorz.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104048551356562 [Primary]

FDA Product Code

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 Number4
Public Version Date2020-05-19
Device Publish Date2016-09-23

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04048551010242 - NA2025-04-07 Telescope Protective Sheath for 497HC
04048551012468 - NA2025-04-07 Irrigation Tube, for cleaning
04048551061343 - NA2025-04-07 15 Touch Screen
04048551067444 - NA2025-04-07 CO2 High Pressure Hose, American/Germ.
04048551069493 - NA2025-04-07 Mandrin, for 204808
04048551069530 - NA2025-04-07 Mandrin, for 204809

Trademark Results [IMAGE1 X-LINK]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IMAGE1 X-LINK
IMAGE1 X-LINK
85806573 4597959 Live/Registered
Karl Storz Endoscopy-America, Inc.
2012-12-19

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