Home GUDID 00858733006024 MI CUFF - Aortic Root Exposure Device
Primary DI 00858733006024
Brand MI CUFF - Aortic Root Exposure Device
Company Biorep Technologies, Inc.
Model 4.0
Catalog number MI-CUFF-001
Device 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.
Published 2024-04-23
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name DWS Instruments, Surgical, Cardiovascular
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DWS Instruments, Surgical, Cardiovascular Cardiovascular 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10858733006021 Package GS1 6 In Commercial Distribution 00858733006024 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10858733006021 10858733006021 00858733006024 00858733006024 858733006024 0858733006024
GMDN Terms# Term, Definition table Term Definition Aortic root retraction system An assembly of devices intended to be used during aortic valve replacement via aortotomy to facilitate temporary stabilization of the aortic root for improved aortic valve site exposure, visualization and tissue tension. It consists of a circular frame that is placed within the aortic ring, sutures and suture retaining loops, and a deployment device with handle and shaft; it may be used during minimally-invasive and open surgery. This is a single-use device.
Sterilization Methods# Method table Method Radiation Sterilization
Regulatory Flags# DUNS number 073724333 Device count 1 Premarket exempt true Lot or batch true Expiration date on label true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00858733006239 DeTACH - Detachable Aortic Cross Clamp Head - Large 1.0 MI-XCHL-851 2024-04-23 00858733006253 DeTACH - Detachable Aortic Cross Clamp Head - Small 1.0 MI-XCHS-551 2024-04-22 00858733006345 DeTACH - Detachable Aortic Cross Clamp Head - Medium 1.0 MI-XCHM-651 2024-04-23 00858733006284 DeTACH Aortic Cross Clamp Delivery Device 1.0 MI-XCDD-001 2024-04-23 00858733006291 DeTACH Aortic Cross Clamp Quick Release Device 1.0 MI-XCQR-001 2024-04-23 00861361000234 Irrigation Syringe Attachment 1.0 ISA-001 2025-02-14 00861361000241 Irrigation Syringe Attachment 1.0 ISA-001 2025-02-14 00858733006000 JOSEPH LAMELAS Knot Pusher 8.0 MI-KP-001 2024-04-23 00858733006017 JOSEPH LAMELAS Atrial Lift System 10.0 MI-ALS-001 2024-04-23 00858733006031 COTIE - Intracorporeal Knot Placement Assist Device and Collar Papillary Muscle 7.0 MI-COTIE-001 2024-04-23 00858733006048 SUTURE BELT - Circumferential Suture Organizer 9.0 MI-ISBA-001 2024-04-23 10858733006007 JOSEPH LAMELAS Knot Pusher 8.0 MI-KP-001 2024-04-23 10858733006014 JOSEPH LAMELAS Atrial Lift System 10.0 MI-ALS-001 2024-04-23 10858733006021 MI CUFF - Aortic Root Exposure Device 4.0 MI-CUFF-001 2024-04-23 10858733006038 COTIE - Intracorporeal Knot Placement Assist Device and Collar Papillary Muscle 7.0 MI-COTIE-001 2024-04-23 10858733006045 SUTURE BELT - Circumferential Suture Organizer 9.0 MI-ISBA-001 2024-04-23 00858733006062 Joseph Lamelas Intercostal Retractor System Rack 5.0 MI-IRS-R-001 2024-04-23 00858733006086 MI Intercostal Retractor System (IRS) 222 Small Blade Set 3.0 MI-IRS-SB-P01 2024-04-23 00858733006093 MI Intercostal Retractor System (IRS) 222 Medium Blade Set 3.0 MI-IRS-MB-P01 2024-04-23 00858733006109 MI Intercostal Retractor System (IRS) 222 Large Blade Set 3.0 MI-IRS-LB-P01 2024-04-23
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