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Hancock™

FDA UDI

Class III (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name
Hancock™ FDA UDI
Generic Name
Pulmonary open-surgery heart valve bioprosthesis FDA UDI
Device Name
CONDUIT HC105-14 HK1 LP 26L FDA UDI
Model / Reference
HC105-14 FDA UDI
Description
CONDUIT HC105-14 HK1 LP 26L FDA UDI

Identifiers

Primary DI / UDI-DI
00643169646490 FDA UDI
PMA Number
P870078 FDA UDI
FDA Product Code
DYE FDA UDI
GMDN Term
Pulmonary open-surgery heart valve bioprosthesis FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
870.3925 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Pulmonary open-surgery heart valve bioprosthesis

Hancock™ by Medtronic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pulmonary open-surgery heart valve bioprosthesis.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic, Inc.

Sources (1)

  • FDA UDI 05095d27-4568-4585-b377-610d1fcf58bb 37 fields · synced Jun 8, 2026