IMAGE 1 S

GUDID 04048551333969

IMAGE1 S H3-ZA

Karl Storz GmbH & Co. KG

Endoscope video camera
Primary Device ID04048551333969
NIH Device Record Key91e97dd1-569d-4dc4-b1ab-6b63066c0f4b
Commercial Distribution StatusIn Commercial Distribution
Brand NameIMAGE 1 S
Version Model NumberTH104
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
GS104048551333969 [Primary]

FDA Product Code

FETEndoscopic video imaging system/component, gastroenterology-urology

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04048551333969]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization;Peracetic Acid


[04048551333969]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization;Peracetic Acid


[04048551333969]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization;Peracetic Acid


[04048551333969]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization;Peracetic Acid


[04048551333969]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization;Peracetic Acid


[04048551333969]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization;Peracetic Acid


[04048551333969]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization;Peracetic Acid


[04048551333969]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization;Peracetic Acid


[04048551333969]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization;Peracetic Acid


[04048551333969]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization;Peracetic Acid


[04048551333969]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization;Peracetic Acid


[04048551333969]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization;Peracetic Acid


[04048551333969]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization;Peracetic Acid


[04048551333969]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization;Peracetic Acid


[04048551333969]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization;Peracetic Acid


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-08-19
Device Publish Date2016-09-23

On-Brand Devices [IMAGE 1 S]

04048551333150IMAGE1 S H3-Z FI
04048551370506IMAGE1 S 4U
04048551356876IMAGE1 S D1
04048551333976IMAGE1 S H3-P
04048551333969IMAGE1 S H3-ZA
04048551333143IMAGE1 S H3-ZI

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.