PowerWire Radiofrequency GuideWire Kit

GUDID 07540299000235

PowerWire RF GuideWire; RFP-100A Connector Cable

Baylis Medical Technologies Inc

Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use
Primary Device ID07540299000235
NIH Device Record Keya077b4ba-b652-4a87-a25b-6230db5a03da
Commercial Distribution StatusIn Commercial Distribution
Brand NamePowerWire Radiofrequency GuideWire Kit
Version Model NumberEWK35-250-12-6A-30-05
Company DUNS240389677
Company NameBaylis Medical Technologies Inc
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com

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Device Identifiers

Device Issuing AgencyDevice ID
GS100685447001072 [Previous]
GS107540299000235 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PDUCatheter For Crossing Total Occlusions

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-04
Device Publish Date2023-06-26

On-Brand Devices [PowerWire Radiofrequency GuideWire Kit]

07540299000273PowerWire RF GuideWire; RFP-100A Connector Cable
07540299000266PowerWire RF GuideWire; RFP-100A Connector Cable
07540299000259PowerWire RF GuideWire; RFP-100A Connector Cable
07540299000242PowerWire RF GuideWire; RFP-100A Connector Cable
07540299000235PowerWire RF GuideWire; RFP-100A Connector Cable
07540299000228PowerWire RF GuideWire; RFP-100A Connector Cable
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