n.a, 091279-06

GUDID 04048551480854

Video Uretero-Renoscope FLEX-XC1

Karl Storz GmbH & Co. KG

Flexible video ureterorenoscope, single-use
Primary Device ID04048551480854
NIH Device Record Keyc98a47f4-4ea3-4c9a-a70c-429af0413194
Commercial Distribution StatusIn Commercial Distribution
Brand Namen.a,
Version Model Number091279-06
Catalog Number091279-06
Company DUNS315731430
Company NameKarl Storz GmbH & Co. KG
Device Count6
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104048551428030 [Primary]
GS104048551480854 [Unit of Use]

FDA Product Code

FGBUreteroscope and accessories, flexible/rigid

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-09
Device Publish Date2024-11-29

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