PowerWire 14 Radiofrequency Guidewire Kit

GUDID 07540299000433

PowerWire 14 Radiofrequency Guidewire, Baylis Connector Cable

Baylis Medical Technologies Inc

Endoscopic electrosurgical electrode, monopolar, single-use
Primary Device ID07540299000433
NIH Device Record Key20f73aed-7f87-4ffe-b4bb-575420b85b7b
Commercial Distribution StatusIn Commercial Distribution
Brand NamePowerWire 14 Radiofrequency Guidewire Kit
Version Model NumberPW14-300-S
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

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS107540299000433 [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 Date2025-12-12
Device Publish Date2025-12-04

On-Brand Devices [PowerWire 14 Radiofrequency Guidewire Kit]

07540299000488PowerWire 14 Radiofrequency Guidewire, Baylis Connector Cable
07540299000471PowerWire 14 Radiofrequency Guidewire, Baylis Connector Cable
07540299000433PowerWire 14 Radiofrequency Guidewire, Baylis Connector Cable
07540299000426PowerWire 14 Radiofrequency Guidewire, Baylis Connector Cable

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