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COTIE - Intracorporeal Knot Placement Assist Device and Collar Papillary Muscle

FDA UDI

Class I (US FDA UDI)

by Biorep Technologies, Inc.

Identity

Trade Name
COTIE - Intracorporeal Knot Placement Assist Device and Collar Papillary Muscle FDA UDI
Generic Name
Suturing unit, single-use FDA UDI
Device Name
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. FDA UDI
Model / Reference
7.0 FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
MI-COTIE-001 FDA UDI
Primary DI / UDI-DI
00858733006031 FDA UDI
FDA Product Code
DWS FDA UDI
GMDN Term
Suturing unit, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
870.4500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI

Category: Suturing unit, single-useHand-held surgical retractor, single-use

COTIE - Intracorporeal Knot Placement Assist Device and Collar Papillary Muscle by Biorep Technologies, Inc. — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Hand-held surgical retractor, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biorep Technologies, Inc.

Sources (1)

  • FDA UDI 67966bc5-9b0d-4e45-a6f6-e348bca0e5bd 34 fields · synced May 30, 2026