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Aortic Root Retractor

FDA UDI

Class I (US FDA UDI)

by LSI Solutions, Inc.

Identity

Trade Name
AORTIC ROOT RETRACTOR FDA UDI
Generic Name
Aortic root retraction system FDA UDI
Device Name
AORTIC ROOT RETRACTOR, LARGE FDA UDI
Model / Reference
080280 FDA UDI
Description
AORTIC ROOT RETRACTOR, LARGE FDA UDI

Identifiers

Catalog Number
080280 FDA UDI
Primary DI / UDI-DI
00850200006568 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

No

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 28 Millimeter FDA UDI

Category: Aortic root retraction system

Aortic Root Retractor 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 afefb148-e978-4ed0-ad6b-05e418b41990 36 fields · synced May 29, 2026