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 Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread 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.