Carter-Thomason (REGARD Distributed)

GUDID 00888937027044

SG Suture Passer with SureGrasp Technology. Distributed under REGARD Brand.

Coopersurgical, Inc.

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• Primary Device ID: 00888937027044
• NIH Device Record Key: 7826bc83-b88d-4fc4-b2c3-7bfb5cf29f58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Carter-Thomason (REGARD Distributed)
• Version Model Number: 534545
• 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	00888937027044 [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.