SUTURE BELT - Circumferential Suture Organizer MI-ISBA-001

GUDID 10858733006045

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.

Biorep Technologies, Inc.

Operative-site suture holder Operative-site suture holder Operative-site suture holder Operative-site suture holder Operative-site suture holder Operative-site suture holder Operative-site suture holder Operative-site suture holder Operative-site suture holder Operative-site suture holder Operative-site suture holder
Primary Device ID10858733006045
NIH Device Record Key07438995-7d52-4f3e-bb3a-832184c73fce
Commercial Distribution StatusIn Commercial Distribution
Brand NameSUTURE BELT - Circumferential Suture Organizer
Version Model Number9.0
Catalog NumberMI-ISBA-001
Company DUNS073724333
Company NameBiorep Technologies, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100858733006048 [Primary]
GS110858733006045 [Package]
Contains: 00858733006048
Package: Shelf Box [6 Units]
In Commercial Distribution

FDA Product Code

DWSInstruments, Surgical, Cardiovascular

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10858733006045]

Radiation Sterilization

[10858733006045]

Radiation Sterilization

[10858733006045]

Radiation Sterilization

[10858733006045]

Radiation Sterilization

[10858733006045]

Radiation Sterilization

[10858733006045]

Radiation Sterilization

[10858733006045]

Radiation Sterilization

[10858733006045]

Radiation Sterilization

[10858733006045]

Radiation Sterilization

[10858733006045]

Radiation Sterilization

[10858733006045]

Radiation Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-01
Device Publish Date2024-04-23

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