Identity
- Trade Name
- HANCOCK® FDA UDI
- Generic Name
- Pulmonary open-surgery heart valve bioprosthesis FDA UDI
- Device Name
- CONDUIT HC105-14 HKI LOW POROSITY 10L FDA UDI
- Model / Reference
- HC105-14 FDA UDI
- Description
- CONDUIT HC105-14 HKI LOW POROSITY 10L FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00681490908504 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
- Not 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
MR Conditional FDA UDI
Hancock® by Medtronic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
P870078 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (1)
- FDA UDI 5baf15e9-08d7-458b-81e0-6d83642cbb45 38 fields · synced May 31, 2026