Trifecta™

FDA UDI

Class I (US FDA UDI)

by St. Jude Medical, Inc.

Identity

Trade Name: Trifecta™ FDA UDI
Generic Name: Heart valve annulus sizer, reusable FDA UDI
Model / Reference: 19 mm Sizer FDA UDI

Identifiers

Catalog Number: TF2000-19 FDA UDI
Primary DI / UDI-DI: 05415067005410 FDA UDI
FDA Product Code: DTI FDA UDI
GMDN Term: Heart valve annulus sizer, reusable 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 19 Millimeter FDA UDI

Category: Heart valve annulus sizer, reusable

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

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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 I	Pending data

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Manufacturer

Manufacturer: St. Jude Medical, Inc.

Sources (1)

FDA UDI 1a73c78f-406d-4b61-8ea0-9bcc3e51c1bd 35 fields · synced May 30, 2026