Open Pivot™

FDA UDI

Class I (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name: Open Pivot™ FDA UDI
Generic Name: Heart valve prosthesis holder, reusable FDA UDI
Device Name: ACCY 580 MITRAL SCREW-ON ROTATOR SET EN FDA UDI
Model / Reference: 580 FDA UDI
Description: ACCY 580 MITRAL SCREW-ON ROTATOR SET EN FDA UDI

Identifiers

Primary DI / UDI-DI: 00643169624948 FDA UDI
FDA Product Code: DTI FDA UDI
GMDN Term: Heart valve prosthesis holder, 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 prosthesis holder, reusable

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

Similar devices

Also classified as Heart valve prosthesis holder, reusable.

HEART VALVE ACCESSOR — Edwards Lifesciences LLC · Class I
CARBOMEDICS — CORCYM SRL · Class III
HEART VALVE HANDLE ACCESSORY — Edwards Lifesciences LLC · Class I
1141M MITRIS RESILIA Mitral Valve Handle — Edwards Lifesciences LLC · Class I
A HANDLE COMPATIBLE WITH RING HOLDERS MODELS 5100, 4900, 4100, 4200, 4450 AND 46 — Edwards Lifesciences LLC · Class I
HEART VALVE ACCESSOR — Edwards Lifesciences LLC · Class I
FLEXIBLE HANDLE — Edwards Lifesciences LLC · Class I
Open Pivot™ — MEDTRONIC, 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 acb7a116-5b2f-4d62-be32-861af2b52e8e 34 fields · synced May 30, 2026