Home GUDID 10858733006045 SUTURE BELT - Circumferential Suture Organizer
Primary DI 10858733006045
Brand SUTURE BELT - Circumferential Suture Organizer
Company Biorep Technologies, Inc.
Model 9.0
Catalog number MI-ISBA-001
Device description The Suture Belt device is a circumferential surgical suture organizer that mounts to a retractor rack prior to use. The device incorporates a rigid base frame with 24 flexible holding plug inserts that receive and retain suture pairs. Suture retention is achieved by pressing the suture strands into the compression slots found between the rigid base frame and flexible holding plug inserts. The rigid base frame consists of 2 hinged halves which allow for angle adjustment of the individual segments. The attachment arms allow the device to be mounted to the retractor arms. Two spacer components allow the attachment arm height to be adjusted. The device is secured into the desired orientation and segment angle positioning by tightening the immobilizing thumb screws.
Published 2024-04-23
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
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 10858733006045 Package GS1 6 In Commercial Distribution 00858733006048 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 10858733006045 10858733006045 00858733006048 00858733006048 858733006048 0858733006048
GMDN Terms# Term, Definition table Term Definition Operative-site suture holder A device designed to hold suture threads to facilitate their manipulation, positioning and differentiation around the operative site during a surgical procedure. It typically has a circular, oval, or curved shape with grooves or other connecting elements, and is stabilized by attachment to a surgical drape; it may also be attached to an invasive surgical retractor. This is a single-use device.
Sterilization Methods# Method table Method Radiation Sterilization
Regulatory Flags# DUNS number 073724333 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false 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 00858733006024 MI CUFF - Aortic Root Exposure Device 4.0 MI-CUFF-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 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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