N/A

GUDID 06948806353187

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 ID06948806353187
NIH Device Record Key2abce596-f4dc-4276-8e23-a0ea7f41bc49
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberS0856238RM2
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106948806353187 [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 Number2
Public Version Date2019-06-07
Device Publish Date2018-05-17

On-Brand Devices [N/A]

06948806353194Intracardiac Catheter Introducer Kit
06948806353187Intracardiac Catheter Introducer Kit
06948806353170Intracardiac Catheter Introducer Kit
06948806353163Intracardiac Catheter Introducer Kit
06948806353156Intracardiac Catheter Introducer Kit
06948806353149Intracardiac Catheter Introducer Kit
06948806353132Intracardiac Catheter Introducer Kit
06948806353125Intracardiac Catheter Introducer Kit
06948806353118Intracardiac Catheter Introducer Kit
06948806353101Intracardiac Catheter Introducer Kit
06948806353095Intracardiac Catheter Introducer Kit
06948806311040Electrophysiology Catheter
06948806311033Electrophysiology Catheter

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