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Thoratec® Heartmate Ii®, Thread Protector Set

FDA UDI

Class III (US FDA UDI)

by Thoratec Corp

Identity

Trade Name
THORATEC® HEARTMATE II®, THREAD PROTECTOR SET FDA UDI
Generic Name
Cardiothoracic surgical procedure kit, non-medicated, single-use FDA UDI
Model / Reference
105558 FDA UDI

Identifiers

Catalog Number
105558 FDA UDI
Primary DI / UDI-DI
00813024011200 FDA UDI
FDA Product Code
DSQ FDA UDI
GMDN Term
Cardiothoracic surgical procedure kit, non-medicated, single-use 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

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cardiothoracic surgical procedure kit, non-medicated, single-use

Thoratec® Heartmate Ii®, Thread Protector Set by Thoratec Corp — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiothoracic surgical procedure kit, non-medicated, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Thoratec Corp

Sources (1)

  • FDA UDI bd034854-9b15-4280-b750-dd2634d831ab 35 fields · synced May 30, 2026