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Open Pivot™

FDA UDI

Class I (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name
Open Pivot™ FDA UDI
Generic Name
Heart valve prosthesis sizer handle FDA UDI
Device Name
ACCY 558 ACTUATOR PACKAGE AVG FDA UDI
Model / Reference
558 FDA UDI
Description
ACCY 558 ACTUATOR PACKAGE AVG FDA UDI

Identifiers

Primary DI / UDI-DI
00613994959546 FDA UDI
FDA Product Code
DWS FDA UDI
GMDN Term
Heart valve prosthesis sizer handle FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
870.4500 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

No

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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Heart valve prosthesis sizer handle

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 sizer handle.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic, Inc.

Sources (1)

  • FDA UDI 6a2b3d54-1d69-45c1-8304-1104de279a38 34 fields · synced May 30, 2026