ENDOCAMELEON / HOPKINS

GUDID 04048551329528

ENDOCAMELEON® ARTHRO HOPKINS® Telescope

Karl Storz GmbH & Co. KG

Rigid optical arthroscope, reusable Rigid optical arthroscope, reusable Rigid optical arthroscope, reusable Rigid optical arthroscope, reusable Rigid optical arthroscope, reusable Rigid optical arthroscope, reusable Rigid optical arthroscope, reusable Rigid optical arthroscope, reusable Rigid optical arthroscope, reusable Rigid optical arthroscope, reusable Rigid optical arthroscope, reusable Rigid optical arthroscope, reusable Rigid optical arthroscope, reusable Rigid optical arthroscope, reusable Rigid optical arthroscope, reusable Rigid optical arthroscope, reusable Rigid optical arthroscope, reusable
Primary Device ID04048551329528
NIH Device Record Key362394b1-a014-45de-b29e-4de762bcad1d
Commercial Distribution StatusIn Commercial Distribution
Brand NameENDOCAMELEON / HOPKINS
Version Model Number28731AE
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
GS104048551329528 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRXARTHROSCOPE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04048551329528]

Moist Heat or Steam Sterilization


[04048551329528]

Moist Heat or Steam Sterilization


[04048551329528]

Moist Heat or Steam Sterilization


[04048551329528]

Moist Heat or Steam Sterilization


[04048551329528]

Moist Heat or Steam Sterilization


[04048551329528]

Moist Heat or Steam Sterilization


[04048551329528]

Moist Heat or Steam Sterilization


[04048551329528]

Moist Heat or Steam Sterilization


[04048551329528]

Moist Heat or Steam Sterilization


[04048551329528]

Moist Heat or Steam Sterilization


[04048551329528]

Moist Heat or Steam Sterilization


[04048551329528]

Moist Heat or Steam Sterilization


[04048551329528]

Moist Heat or Steam Sterilization


[04048551329528]

Moist Heat or Steam Sterilization


[04048551329528]

Moist Heat or Steam Sterilization


[04048551329528]

Moist Heat or Steam Sterilization


[04048551329528]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-11-17
Device Publish Date2016-09-23

Devices Manufactured by Karl Storz GmbH & Co. KG

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04048438001042 - n.a.2024-03-19 Tubing Set, UNIDRIVE/UNIDRIVE SIII
04048438001233 - n.a.2024-03-19 Gas filter, gas flow 30 l/min
04048438002230 - n.a.2024-03-19 Tubing Set, CLEARVISION II (irrigation)
04048438002964 - n.a.2024-03-19 Tubing Set, ARTHROPUMP Power(irrigation)
04048438003176 - n.a.2024-03-19 Pump Tubing Day Set
04048438005316 - n.a.2024-03-19 Insufflation Tubing Set, with gas filter
04048438005330 - n.a.2024-03-19 Insufflation tubing set, ENDOFLATOR 50

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