Nykanen Radiofrequency Wire

GUDID 00685447000600

Baylis Médicale Cie 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 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 ID00685447000600
NIH Device Record Key53015895-0fef-4039-9620-91153ab8b6c6
Commercial Distribution StatusIn Commercial Distribution
Brand NameNykanen Radiofrequency Wire
Version Model NumberRFP-265
Company DUNS249225954
Company NameBaylis Médicale Cie Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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

Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com

Device Dimensions

Outer Diameter0.024 Inch
Outer Diameter0.024 Inch
Outer Diameter0.024 Inch
Outer Diameter0.024 Inch
Length265 Centimeter
Outer Diameter0.024 Inch
Length265 Centimeter
Outer Diameter0.024 Inch
Length265 Centimeter
Outer Diameter0.024 Inch
Length265 Centimeter
Outer Diameter0.024 Inch
Length265 Centimeter
Outer Diameter0.024 Inch
Length265 Centimeter
Outer Diameter0.024 Inch
Length265 Centimeter
Outer Diameter0.024 Inch
Length265 Centimeter
Outer Diameter0.024 Inch
Length265 Centimeter
Outer Diameter0.024 Inch
Length265 Centimeter
Outer Diameter0.024 Inch
Length265 Centimeter
Outer Diameter0.024 Inch
Length265 Centimeter
Outer Diameter0.024 Inch
Length265 Centimeter
Outer Diameter0.024 Inch
Length265 Centimeter
Outer Diameter0.024 Inch
Length265 Centimeter
Outer Diameter0.024 Inch
Length265 Centimeter
Outer Diameter0.024 Inch
Length265 Centimeter
Outer Diameter0.024 Inch
Length265 Centimeter
Outer Diameter0.024 Inch
Length265 Centimeter
Outer Diameter0.024 Inch
Length265 Centimeter
Outer Diameter0.024 Inch
Length265 Centimeter
Outer Diameter0.024 Inch
Length265 Centimeter
Outer Diameter0.024 Inch
Length265 Centimeter
Outer Diameter0.024 Inch
Length265 Centimeter
Outer Diameter0.024 Inch
Length265 Centimeter
Outer Diameter0.024 Inch
Length265 Centimeter
Outer Diameter0.024 Inch
Length265 Centimeter
Outer Diameter0.024 Inch
Length265 Centimeter
Outer Diameter0.024 Inch
Length265 Centimeter
Outer Diameter0.024 Inch
Length265 Centimeter
Outer Diameter0.024 Inch
Length265 Centimeter
Outer Diameter0.024 Inch
Length265 Centimeter
Outer Diameter0.024 Inch
Length265 Centimeter
Outer Diameter0.024 Inch
Length265 Centimeter
Outer Diameter0.024 Inch
Length265 Centimeter
Outer Diameter0.024 Inch
Length265 Centimeter
Outer Diameter0.024 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100685447000600 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-15

Devices Manufactured by Baylis Médicale Cie Inc

00685447019046 - VersaCross Connect Access Solution for FARADRIVE2024-01-19 1 x VersaCross Connect Transseptal Dilator; 1 x VersaCross RF Wire (including 1 x Connector Cable (Single Use))
00685447019053 - VersaCross Connect Access Solution for FARADRIVE2024-01-19 1 x VersaCross Connect Transseptal Dilator; 1 x VersaCross RF Wire (including 1 x Connector Cable (Single Use))
00685447019060 - VersaCross Connect Access Solution for FARADRIVE2024-01-19 1 x VersaCross Connect Transseptal Dilator; 1 x VersaCross RF Wire (including 1 x Connector Cable (Single Use))
00685447019077 - VersaCross Connect Access Solution for FARADRIVE2024-01-19 1 x VersaCross Connect Transseptal Dilator; 1 x VersaCross RF Wire (including 1 x Connector Cable (Single Use))
00685447005964 - SupraCross Steerable Sheath2023-11-16 SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
00685447005971 - SupraCross Steerable Sheath2023-11-16 SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
00685447005988 - SupraCross Steerable Sheath2023-11-16 SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
00685447006213 - SureFlex Steerable Guiding Sheath2023-11-16 SureFlex Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
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