COTIE - Intracorporeal Knot Placement Assist Device and Collar Papillary Muscle MI-COTIE-001

GUDID 10858733006038

The TIE device is a tourniquet-style surgical instrument used to control the target location of knot seating during precise suture knot tying and delivery applications. The COLLAR device is a flexible surgical retractor designed to retract valve leaflet tissue when inserted within the valve annulus. The device consists of a main body component which extends laterally to become the retraction wings. The distal tips of the retraction wings are bifurcated for additional tissue traction. The posterior aspect of the device has a stiffening rib along the superior border and a stabilization flange along the inferior border. The COLLAR device is available in 2 sizes (small and large) which are packaged together in a disposable set with the TIE device.

Biorep Technologies, Inc.

Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use
Primary Device ID10858733006038
NIH Device Record Key67966bc5-9b0d-4e45-a6f6-e348bca0e5bd
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOTIE - Intracorporeal Knot Placement Assist Device and Collar Papillary Muscle
Version Model Number7.0
Catalog NumberMI-COTIE-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
GS100858733006031 [Primary]
GS110858733006038 [Package]
Contains: 00858733006031
Package: Shelf Box [6 Units]
In Commercial Distribution

FDA Product Code

DWSInstruments, Surgical, Cardiovascular

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10858733006038]

Radiation Sterilization

[10858733006038]

Radiation Sterilization

[10858733006038]

Radiation Sterilization

[10858733006038]

Radiation Sterilization

[10858733006038]

Radiation Sterilization

[10858733006038]

Radiation Sterilization

[10858733006038]

Radiation Sterilization

[10858733006038]

Radiation Sterilization

[10858733006038]

Radiation Sterilization

[10858733006038]

Radiation Sterilization

[10858733006038]

Radiation Sterilization

Device Entry Metadata

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

Devices Manufactured by Biorep Technologies, Inc.

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