Carter-Thomason II Port Closure System

GUDID 20888937002922

Contents: 1 Suture Passer, 1 10/12mm Suture Guide and 1 15mm Suture Guide

Coopersurgical, Inc.

Laparoscopic wound closure thread
Primary Device ID20888937002922
NIH Device Record Key9cc0a8f0-4b01-4787-a9b0-182793a0d250
Commercial Distribution StatusIn Commercial Distribution
Brand NameCarter-Thomason II Port Closure System
Version Model NumberCTI-1015P
Company DUNS801895244
Company NameCoopersurgical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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
GS120888937002922 [Package]
Contains: 60888937002920
Package: [5 Units]
In Commercial Distribution
GS160888937002920 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-18

On-Brand Devices [Carter-Thomason II Port Closure System]

20888937002977Contents: One XL Suture Passer, One 10/12mm XL Suture Guide and One 15mm XL Suture Guide
20888937002922Contents: 1 Suture Passer, 1 10/12mm Suture Guide and 1 15mm Suture Guide
20888937002892Contents: 1 Suture Passer and 1 15mm Suture Guide

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