Carter-Thomason

GUDID 20888937002946

CloseSure System Suture Passer

Coopersurgical, Inc.

Suturing unit, single-use

• Primary Device ID: 20888937002946
• NIH Device Record Key: 9715b9d9-bbed-4959-a4fa-5875d187bf92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Carter-Thomason
• Version Model Number: CTI-SP
• 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: false
• 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	00888937002942 [Primary]
GS1	20888937002946 [Package]; Contains: 00888937002942; Package: [5 Units]; In Commercial Distribution

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: 5
• Public Version Date: 2020-02-06
• Device Publish Date: 2016-08-19

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