GUDID 00763000044404

TOOL 7686L HANDLE ANNULOPLASTY 29L

MEDTRONIC, INC.

Heart valve prosthesis sizer handle
Primary Device ID00763000044404
NIH Device Record Keyfb68132d-095b-4041-ab53-f01ed516315f
Commercial Distribution StatusIn Commercial Distribution
Version Model Number7686L
Company DUNS006261481
Company NameMEDTRONIC, 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

Device Dimensions

Length254 Millimeter
Length254 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000044404 [Primary]

FDA Product Code

DTISIZER, HEART-VALVE, PROSTHESIS

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00763000044404]

Moist Heat or Steam Sterilization


[00763000044404]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-02-25
Device Publish Date2019-01-24

Devices Manufactured by MEDTRONIC, INC.

00199150064052 - NA2025-12-23 CUSTOM PACK BB1B62R41 HLN CHR LNNT
00199150064847 - NA2025-12-22 CUSTOM PACK BB12P57R3 HLO IOM FUS M
00199150064861 - NA2025-12-22 CUSTOM PACK BB12S99R1 EVL NEONAT
00199150065042 - NA2025-12-22 CUSTOM PACK BB8S37R40 HLO PUMP TBL
20199150065244 - NA2025-12-22 CUSTOM PACK 11L77R2 20PK ACC PIGTAI
20199150065268 - NA2025-12-22 CUSTOM PACK BB12G80R3 10PK ACC VAC
00199150065271 - NA2025-12-22 CUSTOM PACK BB7J98R19 EVL 3/8 CIRCU
20199150065343 - NA2025-12-22 CUSTOM PACK 8C82R4 5PK ACC AUTOTRANSFU

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.