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Thoratec® Heartmate Ii®, Outflow Graft With Bend Relief

FDA UDI

Class III (US FDA UDI)

by Thoratec Corp

Identity

Trade Name
THORATEC® HEARTMATE II®, OUTFLOW GRAFT WITH BEND RELIEF FDA UDI
Generic Name
Implantable ventricular circulatory assist system outflow cannula, synthetic polymer FDA UDI
Model / Reference
102563 FDA UDI

Identifiers

Catalog Number
102563 FDA UDI
Primary DI / UDI-DI
00813024010173 FDA UDI
FDA Product Code
DSQ FDA UDI
GMDN Term
Implantable ventricular circulatory assist system outflow cannula, synthetic polymer FDA UDI

Classification

Device Class
Class III 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Implantable ventricular circulatory assist system outflow cannula, synthetic polymer

Thoratec® Heartmate Ii®, Outflow Graft With Bend Relief by Thoratec Corp — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Implantable ventricular circulatory assist system outflow cannula, synthetic polymer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Thoratec Corp

Sources (1)

  • FDA UDI 20e60d43-133e-4ad3-809c-bf6ab489e234 35 fields · synced May 30, 2026