Flex-X / IMAGE 1 S

GUDID 04048551344408

Video Uretero-Renoscope FLEX-XC

Karl Storz GmbH & Co. KG

Flexible video ureterorenoscope, reusable
Primary Device ID04048551344408
NIH Device Record Keyb6294189-463f-4188-8f53-2cb854df494b
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlex-X / IMAGE 1 S
Version Model Number11278VS
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
GS104048551344408 [Primary]

FDA Product Code

FGBUreteroscope and accessories, flexible/rigid

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04048551344408]

Hydrogen Peroxide;Ethylene Oxide;Liquid Chemical;Peracetic Acid


[04048551344408]

Hydrogen Peroxide;Ethylene Oxide;Liquid Chemical;Peracetic Acid


[04048551344408]

Hydrogen Peroxide;Ethylene Oxide;Liquid Chemical;Peracetic Acid


[04048551344408]

Hydrogen Peroxide;Ethylene Oxide;Liquid Chemical;Peracetic Acid


[04048551344408]

Hydrogen Peroxide;Ethylene Oxide;Liquid Chemical;Peracetic Acid


[04048551344408]

Hydrogen Peroxide;Ethylene Oxide;Liquid Chemical;Peracetic Acid


[04048551344408]

Hydrogen Peroxide;Ethylene Oxide;Liquid Chemical;Peracetic Acid


[04048551344408]

Hydrogen Peroxide;Ethylene Oxide;Liquid Chemical;Peracetic Acid


[04048551344408]

Hydrogen Peroxide;Ethylene Oxide;Liquid Chemical;Peracetic Acid


[04048551344408]

Hydrogen Peroxide;Ethylene Oxide;Liquid Chemical;Peracetic Acid


[04048551344408]

Hydrogen Peroxide;Ethylene Oxide;Liquid Chemical;Peracetic Acid


[04048551344408]

Hydrogen Peroxide;Ethylene Oxide;Liquid Chemical;Peracetic Acid


[04048551344408]

Hydrogen Peroxide;Ethylene Oxide;Liquid Chemical;Peracetic Acid


[04048551344408]

Hydrogen Peroxide;Ethylene Oxide;Liquid Chemical;Peracetic Acid


[04048551344408]

Hydrogen Peroxide;Ethylene Oxide;Liquid Chemical;Peracetic Acid


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2024-08-19
Device Publish Date2016-09-23

On-Brand Devices [Flex-X / IMAGE 1 S]

04048551402597Vid. Uretero-Renoscope FLEX-XC
04048551344385Video Uretero-Renoscope FLEX-XC
04048551402603Vid. Uretero-Renoscope FLEX-XC
04048551344408Video Uretero-Renoscope FLEX-XC

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.