DCI

GUDID 04048551006207

Video Mediastinoscope

Karl Storz GmbH & Co. KG

Rigid optical mediastinoscope Rigid optical mediastinoscope Rigid optical mediastinoscope Rigid optical mediastinoscope Rigid optical mediastinoscope Rigid optical mediastinoscope Rigid optical mediastinoscope Rigid optical mediastinoscope Rigid optical mediastinoscope Rigid optical mediastinoscope Rigid optical mediastinoscope Rigid optical mediastinoscope Rigid optical mediastinoscope Rigid optical mediastinoscope Rigid optical mediastinoscope Rigid optical mediastinoscope Rigid optical mediastinoscope
Primary Device ID04048551006207
NIH Device Record Key9dda589f-0504-4bde-bde4-2b623c6025f7
Commercial Distribution StatusIn Commercial Distribution
Brand NameDCI
Version Model Number10971MV
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 Batchtrue
Serial Numberfalse
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
GS104048551006207 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, general & plastic surgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04048551006207]

Moist Heat or Steam Sterilization


[04048551006207]

Moist Heat or Steam Sterilization


[04048551006207]

Moist Heat or Steam Sterilization


[04048551006207]

Moist Heat or Steam Sterilization


[04048551006207]

Moist Heat or Steam Sterilization


[04048551006207]

Moist Heat or Steam Sterilization


[04048551006207]

Moist Heat or Steam Sterilization


[04048551006207]

Moist Heat or Steam Sterilization


[04048551006207]

Moist Heat or Steam Sterilization


[04048551006207]

Moist Heat or Steam Sterilization


[04048551006207]

Moist Heat or Steam Sterilization


[04048551006207]

Moist Heat or Steam Sterilization


[04048551006207]

Moist Heat or Steam Sterilization


[04048551006207]

Moist Heat or Steam Sterilization


[04048551006207]

Moist Heat or Steam Sterilization


[04048551006207]

Moist Heat or Steam Sterilization


[04048551006207]

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

On-Brand Devices [DCI]

04048551322062Distending Video Mediastinoscope
04048551242889Distending Video Mediastinoscope
04048551006214Video Mediastinoscope
04048551006207Video Mediastinoscope

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