Hancock™

GUDID 00763000517809

CONDUIT HC150-16 HK1 MO 26L

MEDTRONIC, INC.

Pulmonary open-surgery heart valve bioprosthesis

• Primary Device ID: 00763000517809
• NIH Device Record Key: dc2fe64a-e0af-433f-b3f0-5398347e3343
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hancock™
• Version Model Number: HC150-16
• 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: false
• 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
• 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
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Room temp storage up to 25°C (77°F) is satisfactory provided the conduit is not exposed to sunlight or other ultraviolet light sources or placed where significant temp fluctuations may occur
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Room temp storage up to 25°C (77°F) is satisfactory provided the conduit is not exposed to sunlight or other ultraviolet light sources or placed where significant temp fluctuations may occur
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Room temp storage up to 25°C (77°F) is satisfactory provided the conduit is not exposed to sunlight or other ultraviolet light sources or placed where significant temp fluctuations may occur
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Room temp storage up to 25°C (77°F) is satisfactory provided the conduit is not exposed to sunlight or other ultraviolet light sources or placed where significant temp fluctuations may occur
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Room temp storage up to 25°C (77°F) is satisfactory provided the conduit is not exposed to sunlight or other ultraviolet light sources or placed where significant temp fluctuations may occur
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Room temp storage up to 25°C (77°F) is satisfactory provided the conduit is not exposed to sunlight or other ultraviolet light sources or placed where significant temp fluctuations may occur
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Room temp storage up to 25°C (77°F) is satisfactory provided the conduit is not exposed to sunlight or other ultraviolet light sources or placed where significant temp fluctuations may occur
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Room temp storage up to 25°C (77°F) is satisfactory provided the conduit is not exposed to sunlight or other ultraviolet light sources or placed where significant temp fluctuations may occur
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Room temp storage up to 25°C (77°F) is satisfactory provided the conduit is not exposed to sunlight or other ultraviolet light sources or placed where significant temp fluctuations may occur
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Room temp storage up to 25°C (77°F) is satisfactory provided the conduit is not exposed to sunlight or other ultraviolet light sources or placed where significant temp fluctuations may occur
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Room temp storage up to 25°C (77°F) is satisfactory provided the conduit is not exposed to sunlight or other ultraviolet light sources or placed where significant temp fluctuations may occur
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Room temp storage up to 25°C (77°F) is satisfactory provided the conduit is not exposed to sunlight or other ultraviolet light sources or placed where significant temp fluctuations may occur
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Room temp storage up to 25°C (77°F) is satisfactory provided the conduit is not exposed to sunlight or other ultraviolet light sources or placed where significant temp fluctuations may occur
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Room temp storage up to 25°C (77°F) is satisfactory provided the conduit is not exposed to sunlight or other ultraviolet light sources or placed where significant temp fluctuations may occur

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000517809 [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: 2
• Public Version Date: 2025-05-22
• Device Publish Date: 2021-05-28

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
• 00763000517830: CONDUIT HC15022 HK1 MO 26L
• 00763000517847: CONDUIT HC150-25 HK1 MO 26L
• 00763000517823: CONDUIT HC150-20 HK1 MO 26L
• 00763000517816: CONDUIT HC150-18 HK1 MO 26L
• 00763000517809: CONDUIT HC150-16 HK1 MO 26L