HALOGEN LIGHT SOURCE

GUDID 04953170024511

CLK-4 120V SIMPLIFIED LIGHT SOURCE

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscopic light source, line-powered
Primary Device ID04953170024511
NIH Device Record Key8bf5d423-0cf5-42cc-aa3a-bd31ac05bf1a
Commercial Distribution StatusIn Commercial Distribution
Brand NameHALOGEN LIGHT SOURCE
Version Model NumberOLYMPUS CLK-4
Company DUNS711789789
Company NameOLYMPUS MEDICAL SYSTEMS CORP.
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)401-1086
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Device Identifiers

Device Issuing AgencyDevice ID
GS104953170024511 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FGAKit, nephroscope

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-21
Device Publish Date2016-09-21

On-Brand Devices [HALOGEN LIGHT SOURCE]

04953170024528OLYMPUS CLK-4
04953170024511CLK-4 120V SIMPLIFIED LIGHT SOURCE
04953170024481CLH-SC
04953170024474CLH-SC
04953170024467CLH-SC 150W HALOGEN LIGHT SOUR CE
04953170024429CLH-250
04953170024412CLH-250W HALOGEN LIGHT SOURCE

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