Identity
- Trade Name
- HeartMate 3™ FDA UDI
- Generic Name
- Vascular graft tunneller FDA UDI
- Device Name
- Tunneling Lance and Handle FDA UDI
- Model / Reference
- 10010372GBL FDA UDI
- Description
- Tunneling Lance and Handle FDA UDI
Identifiers
- Catalog Number
- 10010372GBL FDA UDI
- Primary DI / UDI-DI
- 05415067038432 FDA UDI
- PMA Number
- P160054 FDA UDI
- FDA Product Code
- DSQ FDA UDI
- GMDN Term
- Vascular graft tunneller FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Vascular graft tunneller
HeartMate 3™ by Thoratec Corp — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
P160054 also covers:
- HeartMate 3™ — Thoratec Corp
- HeartMate 3™ — Thoratec Corp
- HeartMate 3™ — Thoratec Corp
- HeartMate 3™ — Thoratec Corp
- HeartMate 3™ — Thoratec Corp
- HeartMate 3™ — Thoratec Corp
- HeartMate 3™ — Thoratec Corp
- HeartMate 3™ — Thoratec Corp
- HeartMate 3™ — Thoratec Corp
- HeartMate 3™ — Thoratec Corp
- HeartMate 3™ — Thoratec Corp
- HeartMate 3™ — Thoratec Corp
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 |
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Manufacturer
- Manufacturer
- Thoratec Corp
Sources (1)
- FDA UDI 11746482-f853-4d79-a7e1-55f8de4f88c6 37 fields · synced Jun 8, 2026