FDA.reportPublic FDA data

COTIE - Intracorporeal Knot Placement Assist Device and Collar Papillary Muscle

Primary DI
00858733006031
Brand
COTIE - Intracorporeal Knot Placement Assist Device and Collar Papillary Muscle
Company
Biorep Technologies, Inc.
Model
7.0
Catalog number
MI-COTIE-001
Device 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.
Published
2024-04-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
10858733006038PackageGS16In Commercial Distribution
00858733006031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085873300603810858733006038
00858733006031008587330060318587330060310858733006031

GMDN Terms#

Term, Definition table
TermDefinition
Suturing unit, single-useA non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure; it may also knot, cut and/or tighten the sutures/ligature loop during or after placement. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
073724333
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
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
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
10858733006045SUTURE BELT - Circumferential Suture Organizer9.0MI-ISBA-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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776407315MillenniumAvalign Technologies, Inc.DWS2026-07-28
00190776407360MillenniumAvalign Technologies, Inc.DWS2026-07-28
00190776405830MillenniumAvalign Technologies, Inc.DWS2026-07-26
03661219438663DELACROIX-CHEVALIERLANDANGERDWS2026-07-25
00190776404222MillenniumAvalign Technologies, Inc.DWS2026-07-24
00190776405748MillenniumAvalign Technologies, Inc.DWS2026-07-24
00190776405779MillenniumAvalign Technologies, Inc.DWS2026-07-24
00190776403973MillenniumAvalign Technologies, Inc.DWS2026-07-22
00190776403348MillenniumAvalign Technologies, Inc.DWS2026-07-21
00190776403683MillenniumAvalign Technologies, Inc.DWS2026-07-21
00190776403768MillenniumAvalign Technologies, Inc.DWS2026-07-21
00190776400521MillenniumAvalign Technologies, Inc.DWS2026-07-19
00190776402051MillenniumAvalign Technologies, Inc.DWS2026-07-19
00190776402068MillenniumAvalign Technologies, Inc.DWS2026-07-19
00190776400309MillenniumAvalign Technologies, Inc.DWS2026-07-17
04058749009347NAFehling Instruments GmbH & Co. KGDWS2026-07-17
04058749010060NAFehling Instruments GmbH & Co. KGDWS2026-07-17
04058749122671NAFehling Instruments GmbH & Co. KGDWS2026-07-17
04058749122725NAFehling Instruments GmbH & Co. KGDWS2026-07-17
04058749122794NAFehling Instruments GmbH & Co. KGDWS2026-07-17
04058749125917NAFehling Instruments GmbH & Co. KGDWS2026-07-17
00190776397197MillenniumAvalign Technologies, Inc.DWS2026-07-16
00190776395643MillenniumAvalign Technologies, Inc.DWS2026-07-14
00190776396763MillenniumAvalign Technologies, Inc.DWS2026-07-14
03661219510970LANDANGERLANDANGERDWS2026-07-12
03661219512660DELACROIX-CHEVALIERLANDANGERDWS2026-07-12
03661219528371LANDANGERLANDANGERDWS2026-07-12
00850012846710ValveVaultLSI Solutions, Inc.DWS2026-07-08
03661219140238DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219141648DELACROIX-CHEVALIERLANDANGERDWS2026-07-08