Hancock™

GUDID 00643169646582

CONDUIT HC15018 HK1 MO 26L

MEDTRONIC, INC.

Pulmonary heart valve bioprosthesis

• Primary Device ID: 00643169646582
• NIH Device Record Key: 5545da90-cf14-4aab-adce-3b976c946dd1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hancock™
• Version Model Number: HC15018
• 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	00643169646582 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P790007

FDA Product Code

• LWR: heart-valve, non-allograft tissue

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: 2016-12-12

On-Brand Devices [Hancock™]

• 00643169646612: CONDUIT HC15025 HK1 MO 26L
• 00643169646605: CONDUIT HC15022 HK1 MO 26L
• 00643169646599: CONDUIT HC15020 HK1 MO 26L
• 00643169646582: CONDUIT HC15018 HK1 MO 26L
• 00643169646575: CONDUIT HC15016 HK1 MO 26L
• 00643169646568: CONDUIT HC150-14 HK1 MO 26L
• 00643169646551: CONDUIT HC150-12 HK1 MO 26L
• 00643169646544: CONDUIT HC105-26 HK1 LP 26L
• 00643169646537: CONDUIT HC105-22 HK1 LP 26L
• 00643169646520: CONDUIT HC105-20 HK1 LP 26L
• 00643169646513: CONDUIT HC105-18 HK1 LP 26L
• 00643169646506: CONDUIT HC105-16 HK1 LP 26L
• 00643169646490: CONDUIT HC105-14 HK1 LP 26L
• 00643169646483: CONDUIT HC105-12 HK1 LP 26L