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Trifecta™

FDA UDI

Class I (US FDA UDI)

by St. Jude Medical, Inc.

Identity

Trade Name
Trifecta™ FDA UDI
Generic Name
Heart valve prosthesis sizer handle FDA UDI
Device Name
Valve Rigid Holder Handle FDA UDI
Model / Reference
Valve Series Rigid Holder Handle FDA UDI
Description
Valve Rigid Holder Handle FDA UDI

Identifiers

Catalog Number
T2002-R FDA UDI
Primary DI / UDI-DI
05415067018267 FDA UDI
FDA Product Code
DTI FDA UDI
GMDN Term
Heart valve prosthesis sizer handle FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
870.3945 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Heart valve prosthesis sizer handle

Trifecta™ by St. Jude Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Heart valve prosthesis sizer handle.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
St. Jude Medical, Inc.

Sources (1)

  • FDA UDI cd8f21a0-4987-48f3-9f1b-305299e56623 35 fields · synced Jun 6, 2026