HANCOCK II ULTRA®

GUDID 00643169534087

VLV T505U221 HKII AORULT CII NNA US TEMP

MEDTRONIC, INC.

Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis
Primary Device ID00643169534087
NIH Device Record Keya4fc90c5-2822-4d59-8e68-9fb3e00e7442
Commercial Distribution StatusIn Commercial Distribution
Brand NameHANCOCK II ULTRA®
Version Model NumberT505U221
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

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
GS100643169534087 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYEreplacement Heart-valve

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-10-21

On-Brand Devices [HANCOCK II ULTRA®]

00613994772756VALVE T505U229 HKII AOR ULT CINCHII US
00613994772749VALVE T505U227 HKII AOR ULT CINCHII US
00613994772732VALVE T505U225 HKII AOR ULT CINCHII US
00613994772725VALVE T505U223 HKII AOR ULT CINCHII US
00613994772718VALVE T505U221 HKII AOR ULT CINCHII US
00643169000292VLV T505U229 HKII AOR ULT CII US TEMP IN
00643169000278VLV T505U227 HKII AOR ULT CII US TEMP IN
00643169000254VLV T505U225 HKII AOR ULT CII US TEMP IN
00643169594616VLV T505U229 HKII AORULT CII NNA US PEEK
00643169594609VLV T505U227 HKII AORULT CII NNA US PEEK
00643169594593VLV T505U225 HKII AORULT CII NNA US PEEK
00643169594586VLV T505U223 HKII AORULT CII NNA US PEEK
00643169594579VLV T505U221 HKII AORULT CII NNA US PEEK
00643169594562VLV T505U229 HKII AORULT CII US PEEK
00643169594555VLV T505U227 HKII AORULT CII US PEEK
00643169594548VLV T505U225 HKII AORULT CII US PEEK
00643169594531VLV T505U223 HKII AORULT CII US PEEK
00643169594524VLV T505U221 HKII AORULT CII US PEEK
00643169534124VLV T505U229 HKII AORULT CII NNA US TEMP
00643169534117VLV T505U227 HKII AORULT CII NNA US TEMP
00643169534100VLV T505U225 HKII AORULT CII NNA US TEMP
00643169534094VLV T505U223 HKII AORULT CII NNA US TEMP
00643169534087VLV T505U221 HKII AORULT CII NNA US TEMP

Trademark Results [HANCOCK II ULTRA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HANCOCK II ULTRA
HANCOCK II ULTRA
78470219 3395756 Live/Registered
Medtronic, Inc.
2004-08-19

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