Carter-thomason CloseSure System XL

GUDID 20888937002960

Contents: One Suture Passer XL, one 10/12mm Pilot Guide XL and one 15mm Pilot Guide XL

Coopersurgical, Inc.

Laparoscopic wound closure thread

• Primary Device ID: 20888937002960
• NIH Device Record Key: 379ad16d-30c8-4da7-a1fe-560b57719ac3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Carter-thomason CloseSure System XL
• Version Model Number: CTXL
• 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	20888937002960 [Package]; Contains: 60888937002968; Package: [3 Units]; In Commercial Distribution
GS1	60888937002968 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-12
• Device Publish Date: 2016-08-18

Devices Manufactured by Coopersurgical, Inc.

• 00888937018240 - Lone Star® IRI Delivery: 2024-07-01 Lone Star® IRI Delivery Tube Replacement
• 00888937026597 - LEEP PRECISION™ Smoke Evacuator: 2024-06-25 LEEP PRECISION™ Smoke Evacuator (230 VAC)
• 60888937027176 - ERPeak: 2024-04-18 IVD Sample kit
• 60888937027183 - ERPeak: 2024-04-18 IVD Sample kit
• 60888937027190 - ERPeak: 2024-04-18 IVD Sample kit
• 60888937027206 - ERPeak: 2024-04-18 IVD Sample kit
• 00888937026870 - Mara Console: 2024-03-21 Mara Console- Endometrial Ablation
• 00888937023817 - K-Systems: 2024-02-27 L126 IVF, Standard Heat Right