Carter-Thomason (REGARD Distributed)

GUDID 20888937027031

Carter-Thomason CloseSure System, 1 Box of 5 Systems Distributed under REGARD Brand

Coopersurgical, Inc.

Laparoscopic wound closure thread

• Primary Device ID: 20888937027031
• NIH Device Record Key: 839a2799-b368-4db5-87e4-6552405a9549
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Carter-Thomason (REGARD Distributed)
• Version Model Number: 75926
• 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	20888937027031 [Package]; Contains: 60888937027039; Package: Box [5 Units]; In Commercial Distribution
GS1	60888937027039 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-06
• Device Publish Date: 2022-09-28

On-Brand Devices [Carter-Thomason (REGARD Distributed)]

• 20888937027031: Carter-Thomason CloseSure System, 1 Box of 5 Systems Distributed under REGARD Brand
• 00888937027044: SG Suture Passer with SureGrasp Technology. Distributed under REGARD Brand.