S0806332L1

GUDID 06948806353026

Intracardiac Catheter Introducer Kit

Synaptic Medical, Ltd.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 06948806353026
• NIH Device Record Key: 816fa7a9-018d-42e3-98b5-dd5bb27350cd
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: S0806332L1
• Catalog Number: S0806332L1
• 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: service@synapticmed.com.cn
• Phone: +861051297209
• Email: service@synapticmed.com.cn
• Phone: +861051297209
• Email: service@synapticmed.com.cn
• Phone: +861051297209
• Email: service@synapticmed.com.cn
• Phone: +861051297209
• Email: service@synapticmed.com.cn
• Phone: +861051297209
• Email: service@synapticmed.com.cn
• Phone: +861051297209
• Email: service@synapticmed.com.cn
• Phone: +861051297209
• Email: service@synapticmed.com.cn
• Phone: +861051297209
• Email: service@synapticmed.com.cn
• Phone: +861051297209
• Email: service@synapticmed.com.cn
• Phone: +861051297209
• Email: service@synapticmed.com.cn
• Phone: +861051297209
• Email: service@synapticmed.com.cn
• Phone: +861051297209
• Email: service@synapticmed.com.cn
• Phone: +861051297209
• Email: service@synapticmed.com.cn
• Phone: +861051297209
• Email: service@synapticmed.com.cn
• Phone: +861051297209
• Email: service@synapticmed.com.cn
• Phone: +861051297209
• Email: service@synapticmed.com.cn
• Phone: +861051297209
• Email: service@synapticmed.com.cn

Device Dimensions

• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	06948806353026 [Primary]

FDA Product Code

• DYB: Introducer, Catheter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-06-07
• Device Publish Date: 2016-11-15

Devices Manufactured by Synaptic Medical, Ltd.

• 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: 2019-06-07Intracardiac 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