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Avr Navigator™

FDA UDI

Class I (US FDA UDI)

by LSI Solutions, Inc.

Identity

Trade Name
AVR NAVIGATOR™ FDA UDI
Generic Name
Aortic root retraction system FDA UDI
Device Name
AVR NAVIGATOR™ SMALL RETRACTOR WITH DELIVERY DEVICE FDA UDI
Model / Reference
081446 FDA UDI
Description
AVR NAVIGATOR™ SMALL RETRACTOR WITH DELIVERY DEVICE FDA UDI

Identifiers

Catalog Number
081446 FDA UDI
Primary DI / UDI-DI
00850012846291 FDA UDI
FDA Product Code
DWS FDA UDI
GMDN Term
Aortic root retraction system 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

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Lumen/Inner Diameter — 19 Millimeter FDA UDI

Category: Aortic root retraction system

Avr Navigator™ by LSI Solutions, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Aortic root retraction system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
LSI Solutions, Inc.

Sources (1)

  • FDA UDI c7931003-eb2f-4157-921d-f74d81e198e8 36 fields · synced May 30, 2026