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

Devices Manufactured by MEDTRONIC, INC.

20763000974996 - NA2024-09-17 CUSTOM PACK BB11J93R1 5PK OMCE
20763000975016 - NA2024-09-17 CUSTOM PACK BB10M39R3 10PK VAMP/ACC
00763000975197 - NA2024-09-17 CUSTOM PACK BB8G55R17 A PACK
00763000974190 - NA2024-09-16 CUSTOM PACK HY9L80R7 SADT FUS
00763000974251 - NA2024-09-16 CUSTOM PACK HY4D49R18 LEFT HBY
00763000975135 - NA2024-09-16 CUSTOM PACK BB12G92R4 L PEDI/S ADUL
00763000974572 - NA2024-09-10 CUSTOM PACK BB3X42R20 UNV
20763000181080 - NA2024-09-09 CABLE 5833SL SURGICAL5PK DISP

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.