Carter-Thomason

GUDID 20888937000096

Carter-Thomason CloseSure System, 1 Box of 5 Systems

Coopersurgical, Inc.

Laparoscopic wound closure thread

• Primary Device ID: 20888937000096
• NIH Device Record Key: 2f01ccab-3cab-42eb-9bd7-0d8ab915de88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Carter-Thomason
• Version Model Number: CTI-512N
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	20888937000096 [Package]; Contains: 60888937000094; Package: [1 Units]; In Commercial Distribution
GS1	60888937000094 [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: 2016-09-23

On-Brand Devices [Carter-Thomason]

• 20888937000096: Carter-Thomason CloseSure System, 1 Box of 5 Systems
• 20888937002953: SG Suture Passer with SureGrasp Technology
• 20888937002946: CloseSure System Suture Passer