Nykanen Radiofrequency Wire kit

GUDID 07540299000174

Nykanen Radiofrequency Wire; RFP-100A Connector Cable (single use)

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 ID07540299000174
NIH Device Record Key202863e1-8c81-4294-af28-5c84c8c58a1a
Commercial Distribution StatusIn Commercial Distribution
Brand NameNykanen Radiofrequency Wire kit
Version Model NumberRFK-265
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
GS100685447000976 [Previous]
GS107540299000174 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

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

Devices Manufactured by Baylis Medical Technologies Inc

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07540299000396 - PowerWire Pro Radiofrequency Guidewire Kit2024-03-26 PowerWire Pro RF Guidewire; RFP-100A Connector Cable
07540299000402 - PowerWire Pro Radiofrequency Guidewire Kit2024-03-26 PowerWire Pro RF Guidewire; RFP-100A Connector Cable
07540299000419 - PowerWire Pro Radiofrequency Guidewire Kit2024-03-26 PowerWire Pro RF Guidewire; RFP-100A Connector Cable
07540299000167 - RFP-100A Connector Cable2023-07-07
07540299000174 - Nykanen Radiofrequency Wire kit2023-07-04Nykanen Radiofrequency Wire; RFP-100A Connector Cable (single use)
07540299000174 - Nykanen Radiofrequency Wire kit2023-07-04 Nykanen Radiofrequency Wire; RFP-100A Connector Cable (single use)
07540299000181 - ProTrack Microcatheter2023-07-04
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