S08574LV

GUDID 06948806322107

Steerable Intracardiac Catheter Introducer Kit

Synaptic Medical, Ltd.

Cardiac transseptal access set

• Primary Device ID: 06948806322107
• NIH Device Record Key: e6625dd8-e020-49a8-8863-1a502a7b16ae
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: S08574LV
• Catalog Number: S08574LV
• Company DUNS: 421256891
• Company Name: Synaptic Medical, Ltd.
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +861051297209
• Email: regulatory@synapticmed.com
• Phone: +861051297209
• Email: regulatory@synapticmed.com
• Phone: +861051297209
• Email: regulatory@synapticmed.com
• Phone: +861051297209
• Email: regulatory@synapticmed.com
• Phone: +861051297209
• Email: regulatory@synapticmed.com
• Phone: +861051297209
• Email: regulatory@synapticmed.com
• Phone: +861051297209
• Email: regulatory@synapticmed.com
• Phone: +861051297209
• Email: regulatory@synapticmed.com
• Phone: +861051297209
• Email: regulatory@synapticmed.com
• Phone: +861051297209
• Email: regulatory@synapticmed.com
• Phone: +861051297209
• Email: regulatory@synapticmed.com

Device Dimensions

• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	06948806322107 [Primary]

FDA Product Code

• DYB: Introducer, Catheter

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: 2024-12-16
• Device Publish Date: 2024-12-06

Devices Manufactured by Synaptic Medical, Ltd.

• 06948806322107 - NA: 2024-12-16Steerable Intracardiac Catheter Introducer Kit
• 06948806322107 - NA: 2024-12-16 Steerable Intracardiac Catheter Introducer Kit
• 06948806313914 - NA: 2020-09-14 Cable, Electrode
• 06948806313921 - NA: 2020-09-14 Cable, Electrode
• 06948806313938 - NA: 2020-09-14 Cable, Electrode
• 06948806353019 - NA: 2019-06-07 Intracardiac Catheter Introducer Kit
• 06948806353026 - NA: 2019-06-07 Intracardiac Catheter Introducer Kit
• 06948806353033 - NA: 2019-06-07 Intracardiac Catheter Introducer Kit
• 06948806353040 - NA: 2019-06-07 Intracardiac Catheter Introducer Kit