S0856238R0

GUDID 06948806353057

Intracardiac Catheter Introducer Kit

Synaptic Medical, Ltd.

Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable
Primary Device ID06948806353057
NIH Device Record Keydf803e5e-fbeb-4318-8248-9be3b2460894
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberS0856238R0
Catalog NumberS0856238R0
Company DUNS421256891
Company NameSynaptic Medical, Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+861051297209
Emailservice@synapticmed.com.cn
Phone+861051297209
Emailservice@synapticmed.com.cn
Phone+861051297209
Emailservice@synapticmed.com.cn
Phone+861051297209
Emailservice@synapticmed.com.cn
Phone+861051297209
Emailservice@synapticmed.com.cn
Phone+861051297209
Emailservice@synapticmed.com.cn
Phone+861051297209
Emailservice@synapticmed.com.cn
Phone+861051297209
Emailservice@synapticmed.com.cn
Phone+861051297209
Emailservice@synapticmed.com.cn
Phone+861051297209
Emailservice@synapticmed.com.cn
Phone+861051297209
Emailservice@synapticmed.com.cn
Phone+861051297209
Emailservice@synapticmed.com.cn
Phone+861051297209
Emailservice@synapticmed.com.cn
Phone+861051297209
Emailservice@synapticmed.com.cn
Phone+861051297209
Emailservice@synapticmed.com.cn
Phone+861051297209
Emailservice@synapticmed.com.cn
Phone+861051297209
Emailservice@synapticmed.com.cn
Phone+861051297209
Emailservice@synapticmed.com.cn

Device Dimensions

Catheter Gauge8.5 French
Catheter Gauge8.5 French
Catheter Gauge8.5 French
Catheter Gauge8.5 French
Catheter Gauge8.5 French
Catheter Gauge8.5 French
Catheter Gauge8.5 French
Catheter Gauge8.5 French
Catheter Gauge8.5 French
Catheter Gauge8.5 French
Catheter Gauge8.5 French
Catheter Gauge8.5 French
Catheter Gauge8.5 French
Catheter Gauge8.5 French
Catheter Gauge8.5 French
Catheter Gauge8.5 French
Catheter Gauge8.5 French
Catheter Gauge8.5 French

Device Identifiers

Device Issuing AgencyDevice ID
GS106948806353057 [Primary]

FDA Product Code

DYBIntroducer, Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-06-07
Device Publish Date2016-11-15

Devices Manufactured by Synaptic Medical, Ltd.

06948806313914 - NA2020-09-14 Cable, Electrode
06948806313921 - NA2020-09-14 Cable, Electrode
06948806313938 - NA2020-09-14 Cable, Electrode
06948806353019 - NA2019-06-07 Intracardiac Catheter Introducer Kit
06948806353026 - NA2019-06-07 Intracardiac Catheter Introducer Kit
06948806353033 - NA2019-06-07 Intracardiac Catheter Introducer Kit
06948806353040 - NA2019-06-07 Intracardiac Catheter Introducer Kit
06948806353057 - NA2019-06-07Intracardiac Catheter Introducer Kit
06948806353057 - NA2019-06-07 Intracardiac Catheter Introducer Kit

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.