HANCOCK® II

GUDID 00643169594425

VLV T510C31 HKII MIT CINCH US PEEK

MEDTRONIC, INC.

Mitral heart valve bioprosthesis

• Primary Device ID: 00643169594425
• NIH Device Record Key: edc5ab0a-7f2d-4a8e-a6a7-437ebb876e0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HANCOCK® II
• Version Model Number: T510C31
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169594425 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P980043

FDA Product Code

• DYE: replacement Heart-valve

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-07

On-Brand Devices [HANCOCK® II]

• 00613994760579: VALVE T505C229 HKII AOR CINCHII US
• 00613994760562: VALVE T505C227 HKII AOR CINCHII US
• 00613994760555: VALVE T505C225 HKII AOR CINCHII US
• 00613994760548: VALVE T505C223 HKII AOR CINCHII US
• 00613994760531: VALVE T505C221 HKII AOR CINCHII US
• 00613994687036: VALVE T510C27 HKII MIT CINCH US
• 00613994686961: VALVE T510C25 HKII MIT CINCH US
• 00613994686893: VALVE T510C33 HKII MIT CINCH US
• 00613994686824: VALVE T510C31 HKII MIT CINCH US
• 00613994686756: VALVE T510C29 HKII MIT CINCH US
• 00643169027138: VLV T510C33 HKII MIT CINCH US TEMP IND
• 00643169027121: VLV T510C31 HKII MIT CINCH US TEMP IND
• 00643169027107: VLV T510C29 HKII MIT CINCH US TEMP IND
• 00643169027084: VLV T510C27 HKII MIT CINCH US TEMP IND
• 00643169027060: VLV T510C25 HKII MIT CINCH US TEMP IND
• 00643169000438: VLV T505U223 HKII AOR ULT CII US TEMP IN
• 00643169000414: VLV T505U221 HKII AOR ULT CII US TEMP IN
• 00643169000391: VLV T505C229 HKII AOR CII US TEMP IND
• 00643169000377: VLV T505C227 HKII AOR CII US TEMP IND
• 00643169000353: VLV T505C225 HKII AOR CII US TEMP IND
• 00643169000339: VLV T505C223 HKII AOR CII US TEMP IND
• 00643169000315: VLV T505C221 HKII AOR CII US TEMP IND
• 00643169594463: VLV T510C29 HKII MIT CINCH NNA US PEEK
• 00643169594456: VLV T510C27 HKII MIT CINCH NNA US PEEK
• 00643169594449: VLV T510C25 HKII MIT CINCH NNA US PEEK
• 00643169594432: VLV T510C33 HKII MIT CINCH US PEEK
• 00643169594425: VLV T510C31 HKII MIT CINCH US PEEK
• 00643169594418: VLV T510C29 HKII MIT CINCH US PEEK
• 00643169594401: VLV T510C27 HKII MIT CINCH US PEEK
• 00643169594395: VLV T510C25 HKII MIT CINCH US PEEK
• 00643169594333: VLV T505C229 HKII AOR CII NNA US PEEK
• 00643169594326: VLV T505C227 HKII AOR CII NNA US PEEK
• 00643169594319: VLV T505C225 HKII AOR CII NNA US PEEK
• 00643169594302: VLV T505C223 HKII AOR CII NNA US PEEK
• 00643169594296: VLV T505C221 HKII AOR CII NNA US PEEK
• 00643169594289: VLV T505C229 HKII AOR CII US PEEK
• 00643169594272: VLV T505C227 HKII AOR CII US PEEK
• 00643169594265: VLV T505C225 HKII AOR CII US PEEK
• 00643169594258: VLV T505C223 HKII AOR CII US PEEK
• 00643169594241: VLV T505C221 HKII AOR CII US PEEK
• 00643169534155: VLV T510C29 HKII MIT CINCH NNA US TEMP
• 00643169534148: VLV T510C27 HKII MIT CINCH NNA US TEMP
• 00643169534131: VLV T510C25 HKII MIT CINCH NNA US TEMP
• 00643169534070: VLV T505C229 HKII AOR CII NNA US TEMP
• 00643169534063: VLV T505C227 HKII AOR CII NNA US TEMP
• 00643169534056: VLV T505C225 HKII AOR CII NNA US TEMP
• 00643169534049: VLV T505C223 HKII AOR CII NNA US TEMP
• 00643169534032: VLV T505C221 HKII AOR CII NNA US TEMP