Carter-thomason CloseSure System XL (REGARD Distributed)

GUDID 20888937027055

Contents: One Suture Passer XL, one 10/12mm Pilot Guide XL and one 15mm Pilot Guide XL. Distributed under REGARD Brand.

Coopersurgical, Inc.

Laparoscopic wound closure thread

• Primary Device ID: 20888937027055
• NIH Device Record Key: fbdeadab-070b-4e9e-bede-80d6b28390a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Carter-thomason CloseSure System XL (REGARD Distributed)
• Version Model Number: 733776
• 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	20888937027055 [Package]; Contains: 60888937027053; Package: Box [3 Units]; In Commercial Distribution
GS1	60888937027053 [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

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