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MI CUFF - Aortic Root Exposure Device

FDA UDI

Class I (US FDA UDI)

by Biorep Technologies, Inc.

Identity

Trade Name
MI CUFF - Aortic Root Exposure Device FDA UDI
Generic Name
Aortic root retraction system FDA UDI
Device Name
The CUFF device is a flexible surgical retractor designed for exposure and access purposes when inserted into the aortic root and used to retract aortic wall tissue. The device consists of a main body component with retraction wings which are two-tiered and extend laterally. The posterior aspect of the device has a stabilization flange along the inferior border. Two alignment suture eyelet holes can be found within the medial portion of the stabilization flange. FDA UDI
Model / Reference
4.0 FDA UDI
Description
The CUFF device is a flexible surgical retractor designed for exposure and access purposes when inserted into the aortic root and used to retract aortic wall tissue. The device consists of a main body component with retraction wings which are two-tiered and extend laterally. The posterior aspect of the device has a stabilization flange along the inferior border. Two alignment suture eyelet holes can be found within the medial portion of the stabilization flange. FDA UDI

Identifiers

Catalog Number
MI-CUFF-001 FDA UDI
Primary DI / UDI-DI
00858733006024 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
Sterilization Method
Radiation Sterilization FDA UDI

Category: Aortic root retraction system

MI CUFF - Aortic Root Exposure Device by Biorep Technologies, 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
Biorep Technologies, Inc.

Sources (1)

  • FDA UDI 81650f1f-056d-482b-bf73-452b15458d03 34 fields · synced May 30, 2026