03816700

GUDID 07611819583894

REUSABLE LIGHT

Synthes GmbH

Fibreoptic operating light system
Primary Device ID07611819583894
NIH Device Record Key80b253cf-8c06-4ca6-b487-9a408c4ae320
Commercial Distribution StatusIn Commercial Distribution
Version Model Number03.816.700
Catalog Number03816700
Company DUNS486711679
Company NameSynthes GmbH
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

Customer Support Contacts

Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS107611819583894 [Direct Marking]
GS110705034731094 [Primary]
HIBCCH981038167000 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FQPLamp, operating-room

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07611819583894]

Moist Heat or Steam Sterilization


[07611819583894]

Moist Heat or Steam Sterilization


[07611819583894]

Moist Heat or Steam Sterilization


[07611819583894]

Moist Heat or Steam Sterilization


[07611819583894]

Moist Heat or Steam Sterilization


[07611819583894]

Moist Heat or Steam Sterilization


[07611819583894]

Moist Heat or Steam Sterilization


[07611819583894]

Moist Heat or Steam Sterilization


[07611819583894]

Moist Heat or Steam Sterilization


[07611819583894]

Moist Heat or Steam Sterilization


[07611819583894]

Moist Heat or Steam Sterilization


[07611819583894]

Moist Heat or Steam Sterilization


[07611819583894]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-04-26
Device Publish Date2016-06-30

Devices Manufactured by Synthes GmbH

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10886982349897 - NA2025-09-01 CANNULATED CIRCULAR REAMER 20MM
10886982349903 - NA2025-09-01 CANNULATED CIRCULAR REAMER 22MM
10886982350039 - NA2025-08-15 CRE DRILL GUIDE 15MM
10886982350046 - NA2025-08-15 CRE DRILL GUIDE 18MM
10886982350053 - NA2025-08-15 CRE DRILL GUIDE 20MM
10886982350060 - NA2025-08-15 CRE DRILL GUIDE 25MM

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