GUDID 20643169843107

TORQUE HANDLE AC4006 TJM 5PK

MEDTRONIC, INC.

Torque manipulation device
Primary Device ID20643169843107
NIH Device Record Keyf70633d2-a264-46f0-a12c-4a693686ab66
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberAC4006
Company DUNS006261481
Company NameMEDTRONIC, 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 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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store accessories in a clean, cool and dark area.
Special Storage Condition, SpecifyBetween 0 and 0 *Store accessories in a clean, cool and dark area.

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169843103 [Primary]
GS120643169843107 [Package]
Contains: 00643169843103
Package: PK [5 Units]
In Commercial Distribution

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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-08-06
Device Publish Date2018-07-06

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