D-LIGHT C

GUDID 04048551004654

Cold Light Fountain D-LIGHT C/US SCB

Karl Storz GmbH & Co. KG

Endoscopic light source, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered
Primary Device ID04048551004654
NIH Device Record Key93c3ce4a-0e4e-4b17-ad64-bcc1c1071203
Commercial Distribution StatusIn Commercial Distribution
Brand NameD-LIGHT C
Version Model Number20133620-134
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 Producttrue
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

Customer Support Contacts

Phone424-218-8201
Emailsu.chen@karlstorz.com
Phone424-218-8201
Emailsu.chen@karlstorz.com
Phone424-218-8201
Emailsu.chen@karlstorz.com
Phone424-218-8201
Emailsu.chen@karlstorz.com
Phone424-218-8201
Emailsu.chen@karlstorz.com
Phone424-218-8201
Emailsu.chen@karlstorz.com
Phone424-218-8201
Emailsu.chen@karlstorz.com
Phone424-218-8201
Emailsu.chen@karlstorz.com
Phone424-218-8201
Emailsu.chen@karlstorz.com
Phone424-218-8201
Emailsu.chen@karlstorz.com
Phone424-218-8201
Emailsu.chen@karlstorz.com
Phone424-218-8201
Emailsu.chen@karlstorz.com
Phone424-218-8201
Emailsu.chen@karlstorz.com
Phone424-218-8201
Emailsu.chen@karlstorz.com
Phone424-218-8201
Emailsu.chen@karlstorz.com
Phone+14242188201
Emailregulatory@karlstorz.com
Phone+14242188201
Emailregulatory@karlstorz.com
Phone+14242188201
Emailregulatory@karlstorz.com
Phone+14242188201
Emailregulatory@karlstorz.com
Phone+14242188201
Emailregulatory@karlstorz.com
Phone+14242188201
Emailregulatory@karlstorz.com
Phone+14242188201
Emailregulatory@karlstorz.com
Phone+14242188201
Emailregulatory@karlstorz.com
Phone+14242188201
Emailregulatory@karlstorz.com
Phone+14242188201
Emailregulatory@karlstorz.com
Phone+14242188201
Emailregulatory@karlstorz.com
Phone+14242188201
Emailregulatory@karlstorz.com
Phone+14242188201
Emailregulatory@karlstorz.com
Phone+14242188201
Emailregulatory@karlstorz.com
Phone+14242188201
Emailregulatory@karlstorz.com
Phone+14242188201
Emailregulatory@karlstorz.com
Phone+14242188201
Emailregulatory@karlstorz.com
Phone+14242188201
Emailregulatory@karlstorz.com
Phone+14242188201
Emailregulatory@karlstorz.com
Phone+14242188201
Emailregulatory@karlstorz.com
Phone+14242188201
Emailregulatory@karlstorz.com
Phone+14242188201
Emailregulatory@karlstorz.com
Phone+14242188201
Emailregulatory@karlstorz.com
Phone+14242188201
Emailregulatory@karlstorz.com
Phone+14242188201
Emailregulatory@karlstorz.com
Phone+14242188201
Emailregulatory@karlstorz.com
Phone+14242188201
Emailregulatory@karlstorz.com
Phone+14242188201
Emailregulatory@karlstorz.com
Phone+14242188201
Emailregulatory@karlstorz.com
Phone+14242188201
Emailregulatory@karlstorz.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104048551004654 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OAYLight Source System, Diagnostic Endoscopic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-11
Device Publish Date2014-09-24

Devices Manufactured by Karl Storz GmbH & Co. KG

04048438000984 - n.a.2024-03-19 Patient Tubing Set, for day sets
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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