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
CodeName
DWSInstruments, Surgical, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858733006045PackageGS16In Commercial Distribution
00858733006048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085873300604510858733006045
00858733006048008587330060488587330060480858733006048

GMDN Terms#

Term, Definition table
TermDefinition
Operative-site suture holderA 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 DIBrandModelCatalogPublished
00858733006239DeTACH - Detachable Aortic Cross Clamp Head - Large1.0MI-XCHL-8512024-04-23
00858733006253DeTACH - Detachable Aortic Cross Clamp Head - Small1.0MI-XCHS-5512024-04-22
00858733006345DeTACH - Detachable Aortic Cross Clamp Head - Medium1.0MI-XCHM-6512024-04-23
00858733006284DeTACH Aortic Cross Clamp Delivery Device1.0MI-XCDD-0012024-04-23
00858733006291DeTACH Aortic Cross Clamp Quick Release Device1.0MI-XCQR-0012024-04-23
00861361000234Irrigation Syringe Attachment1.0ISA-0012025-02-14
00861361000241Irrigation Syringe Attachment1.0ISA-0012025-02-14
00858733006000JOSEPH LAMELAS Knot Pusher8.0MI-KP-0012024-04-23
00858733006017JOSEPH LAMELAS Atrial Lift System10.0MI-ALS-0012024-04-23
00858733006024MI CUFF - Aortic Root Exposure Device4.0MI-CUFF-0012024-04-23
00858733006031COTIE - Intracorporeal Knot Placement Assist Device and Collar Papillary Muscle7.0MI-COTIE-0012024-04-23
00858733006048SUTURE BELT - Circumferential Suture Organizer9.0MI-ISBA-0012024-04-23
10858733006007JOSEPH LAMELAS Knot Pusher8.0MI-KP-0012024-04-23
10858733006014JOSEPH LAMELAS Atrial Lift System10.0MI-ALS-0012024-04-23
10858733006021MI CUFF - Aortic Root Exposure Device4.0MI-CUFF-0012024-04-23
10858733006038COTIE - Intracorporeal Knot Placement Assist Device and Collar Papillary Muscle7.0MI-COTIE-0012024-04-23
00858733006062Joseph Lamelas Intercostal Retractor System Rack5.0MI-IRS-R-0012024-04-23
00858733006086MI Intercostal Retractor System (IRS) 222 Small Blade Set3.0MI-IRS-SB-P012024-04-23
00858733006093MI Intercostal Retractor System (IRS) 222 Medium Blade Set3.0MI-IRS-MB-P012024-04-23
00858733006109MI Intercostal Retractor System (IRS) 222 Large Blade Set3.0MI-IRS-LB-P012024-04-23

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