GUDID 00763000318475

HANDLE 7686XL ANNULOPLASTY 29L CE

MEDTRONIC 3F THERAPEUTICS, INC.

Heart valve prosthesis sizer handle
Primary Device ID00763000318475
NIH Device Record Keydb27557f-d074-43e0-a311-43b31b8c707e
Commercial Distribution StatusIn Commercial Distribution
Version Model Number7686XL
Company DUNS079527232
Company NameMEDTRONIC 3F THERAPEUTICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptionfalse
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

Device Dimensions

Length373 Millimeter
Length373 Millimeter
Length373 Millimeter
Length373 Millimeter
Length373 Millimeter
Length373 Millimeter
Length373 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000318475 [Primary]

FDA Product Code

DTJHOLDER, HEART-VALVE, PROSTHESIS

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00763000318475]

Moist Heat or Steam Sterilization


[00763000318475]

Moist Heat or Steam Sterilization


[00763000318475]

Moist Heat or Steam Sterilization


[00763000318475]

Moist Heat or Steam Sterilization


[00763000318475]

Moist Heat or Steam Sterilization


[00763000318475]

Moist Heat or Steam Sterilization


[00763000318475]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-27
Device Publish Date2021-07-19

Devices Manufactured by MEDTRONIC 3F THERAPEUTICS, INC.

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00763000318383 - MOSAIC™2024-08-19 SIZERS 7308C MOSAIC AORTIC 26L CE
00885074426815 - Duran AnCore®2024-03-18 TOOL 7620H HANDLE DURAN ANCORE 14L
00643169402546 - HANCOCK II ULTRA™ SUPRA-X™2023-09-26 SIZERS 7505UX HKII ULT SUPRA-X AOR 26L
00763000318451 - CG Future™2023-02-13 SIZER SET 7638S CG FUTURE 26L CE
00763000318499 - Duran AnCore™2022-10-24 SIZER SET 7620S DURAN ANCORE 26L CE
00763000318482 - Contour 3D™2022-07-11 SIZER SET 7690S CONTOUR 3D 26L CE
00763000318345 - NA2021-07-27 HANDLE 7639 VALVE 26L CE

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