Endoscopic Optical Coupler

GUDID 00643169498310

COUPLER 5189-001 OPTICAL HIGH RESO

MEDTRONIC PS MEDICAL, INC.

Endoscope camera adaptor
Primary Device ID00643169498310
NIH Device Record Key5416f60d-9d55-4e43-a3ba-e7e391b1374d
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndoscopic Optical Coupler
Version Model Number5189-001
Company DUNS089055867
Company NameMEDTRONIC PS MEDICAL, INC.
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)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169498310 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWGENDOSCOPE, NEUROLOGICAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00643169498310]

Ethylene Oxide


[00643169498310]

Ethylene Oxide


[00643169498310]

Ethylene Oxide


[00643169498310]

Ethylene Oxide


[00643169498310]

Ethylene Oxide


[00643169498310]

Ethylene Oxide


[00643169498310]

Ethylene Oxide


[00643169498310]

Ethylene Oxide


[00643169498310]

Ethylene Oxide


[00643169498310]

Ethylene Oxide


[00643169498310]

Ethylene Oxide


[00643169498310]

Ethylene Oxide


[00643169498310]

Ethylene Oxide


[00643169498310]

Ethylene Oxide


[00643169498310]

Ethylene Oxide


[00643169498310]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-06-13

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