Medtronic Open Pivot™

FDA UDI

Class I (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name: Medtronic Open Pivot™ FDA UDI
Generic Name: Heart valve annulus sizer, reusable FDA UDI
Device Name: SIZER SET 577 OPHV STANDARD 26L CE FDA UDI
Model / Reference: 577 FDA UDI
Description: SIZER SET 577 OPHV STANDARD 26L CE FDA UDI

Identifiers

Primary DI / UDI-DI: 00763000318598 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

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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Heart valve annulus sizer, reusable

Medtronic Open Pivot™ by Medtronic, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Heart valve annulus sizer, reusable.

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Tailor™ & Attune™ — ST. JUDE MEDICAL, INC. · Class I
Dafodil™ Pericardial Bioprosthesis Valve — Meril Life Sciences Pvt. Ltd. · Class III
PERCEVAL S — CORCYM SRL · Class I
Tailor™ & Attune™ — ST. JUDE MEDICAL, INC. · Class I
CARBOMEDICS PROSTHETIC HEART VALVES — CORCYM SRL · Class I
Trifecta™ — ST. JUDE MEDICAL, INC. · Class I
On-X Heart Valve Instruments — ON-X LIFE TECHNOLOGIES, INC. · Class I

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: Medtronic, Inc.

Sources (1)

FDA UDI 34d5d240-f4a2-4465-866f-28789db9cd64 35 fields · synced May 30, 2026