GUDID 00681490225922

TORQUE HANDLE AC4006 GDWR 5PK

MEDTRONIC, INC.

Torque manipulation device
Primary Device ID00681490225922
NIH Device Record Keydb43da63-882a-4acf-8ec7-37297e69a03e
Commercial Distribution Discontinuation2016-08-01
Commercial Distribution StatusNot in Commercial Distribution
Version Model NumberAC4006
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100681490225922 [Primary]
GS170681490225921 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTLAdaptor, stopcock, manifold, fitting, cardiopulmonary bypass

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-01
Device Publish Date2016-07-21

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