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 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: 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

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