3f®

GUDID 00643169072541

THV 1000-29 3F AORTIC BIO 29MM 2PC HLDR

MEDTRONIC 3F THERAPEUTICS, INC.

Aortic heart valve bioprosthesis
Primary Device ID00643169072541
NIH Device Record Key65ca2c52-163c-4352-8ad9-111ad6208b81
Commercial Distribution Discontinuation2018-10-05
Commercial Distribution StatusNot in Commercial Distribution
Brand Name3f®
Version Model Number1000-29
Company DUNS079527232
Company NameMEDTRONIC 3F THERAPEUTICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
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
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
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

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169072541 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LWRheart-valve, non-allograft tissue

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-12-13
Device Publish Date2014-09-23

On-Brand Devices [3f®]

00613994868268THV 1000-29 3F AORTIC BIO 29MM
00613994868251THV 1000-27 3F AORTIC BIO 27MM
00613994868244THV 1000-25 3F AORTIC BIO 25MM
00613994868237THV 1000-23 3F AORTIC BIO 23MM
00613994868220THV 1000-21 3F AORTIC BIO 21MM
00613994868213THV 1000-29 3F AORTIC BIO 29MM 1 EA US
00643169072558THV 1000-29 3F AORTIC BIO 29MM 1 EA US
00643169072541THV 1000-29 3F AORTIC BIO 29MM 2PC HLDR
00643169072534THV 1000-27 3F AORTIC BIO 27MM 2PC HLDR
00643169072527THV 1000-25 3F AORTIC BIO 25MM 2PC HLDR
00643169072510THV 1000-23 3F AORTIC BIO 23MM 2PC HLDR
00643169072503THV 1000-21 3F AORTIC BIO 21MM 2PC HLDR
00613994961624THV 1000-21 3F AORTIC BIO 21MM 2PC HLDR
00613994961617THV 1000-23 3F AORTIC BIO 23MM 2PC HLDR
00613994961600THV 1000-25 3F AORTIC BIO 25MM 2PC HLDR
00613994961594THV 1000-27 3F AORTIC BIO 27MM 2PC HLDR
00613994961587THV 1000-29 3F AORTIC BIO 29MM 2PC HLDR
00613994959720THV 1000-29 3F AORTIC BIO 29MM 1 EA US

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