Carter-Thomason II Port Closure System

GUDID 20888937002977

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

Coopersurgical, Inc.

Laparoscopic wound closure thread

• Primary Device ID: 20888937002977
• NIH Device Record Key: 67ae1999-0726-403d-a9b5-31ae9f3d1eb3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Carter-Thomason II Port Closure System
• Version Model Number: CTXL-P
• Company DUNS: 801895244
• Company Name: Coopersurgical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	20888937002977 [Package]; Contains: 60888937002975; Package: [3 Units]; In Commercial Distribution
GS1	60888937002975 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980123

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-05-26

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

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