FSR3XX

GUDID 10653405004608

RE-ORDER TAG

Conmed Corporation

Electrocardiographic lead set, reusable

• Primary Device ID: 10653405004608
• NIH Device Record Key: 601bc3a2-ef62-4914-be85-b711b5f5756f
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: FSR3XX
• Catalog Number: FSR3XX
• Company DUNS: 071595540
• Company Name: Conmed Corporation
• 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	10653405004608 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K933649

FDA Product Code

• DSA: CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2024-06-06
• Device Publish Date: 2016-09-24

Devices Manufactured by Conmed Corporation

• 00810021867373 - CoLink®: 2025-07-11 CoLink® Afx, Locking Screw, 2.7X14.0MM, 2-Pack
• 00810021867380 - CoLink®: 2025-07-11 CoLink® Afx, Locking Screw, 2.7X16.0MM, 2-Pack
• 00810021867403 - CoLink®: 2025-07-11 CoLink® Afx, Locking Screw, 3.5X12.0MM, 2-Pack
• 00810021867410 - CoLink®: 2025-07-11 CoLink® Afx, Locking Screw, 3.5X14.0MM, 2-Pack
• 00810021867427 - CoLink®: 2025-07-11 CoLink® Afx, LOW-PRO CORTICAL SCREW, 3.5X12.0MM, 2-Pack
• 00810021867434 - CoLink®: 2025-07-11 CoLink® Afx, LOW-PRO CORTICAL SCREW, 3.5X14.0MM, 2-Pack
• 08101755018714 - CoLink®: 2025-07-11 CoLink® Afx, Locking Screw, 3.5X10.0MM, 2-Pack
• 08101755018721 - CoLink®: 2025-07-11 CoLink® Afx, Locking Screw, 3.5X16.0MM, 2-Pack