FDA.reportPublic FDA data

Nykanen Radiofrequency Wire

Primary DI
07540299000211
Brand
Nykanen Radiofrequency Wire
Company
Baylis Medical Technologies Inc
Model
RFP-265
Published
2023-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXFCatheter, Septostomy
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXFCatheter, SeptostomyCardiovascular2
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00685447000600PreviousGS10
07540299000211PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00685447000600006854470006006854470006000685447000600
07540299000211075402990002117540299000211

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length265Centimeter
Outer Diameter0.024Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
905-948-5800info@baylismedtech.com

Regulatory Flags#

DUNS number
240389677
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540299000426PowerWire 14 Radiofrequency Guidewire KitPW14-190-S2025-12-04
07540299000433PowerWire 14 Radiofrequency Guidewire KitPW14-300-S2025-12-04
07540299000471PowerWire 14 Radiofrequency Guidewire KitPW14-190-20A2025-12-04
07540299000488PowerWire 14 Radiofrequency Guidewire KitPW14-300-20A2025-12-04
07540299000440 PowerWire Pulse RF Guidewire KitPTK35-250-08-6S2024-09-27
07540299000457 PowerWire Pulse RF Guidewire KitPTK35-250-10-6S2024-09-27
07540299000464 PowerWire Pulse RF Guidewire KitPTK35-250-12-6S2024-09-27
07540299000020AnchorKnot SutureASU-0-W-CL2022-11-16
07540299000037AnchorKnot SutureASU-2-0-WB-CL2022-11-16
07540299000044AnchorKnot SutureASU-2-0-W-CL2022-11-16
07540299000051AnchorKnot SutureASU-2-WB-CL2022-11-16
07540299000068AnchorKnot SutureASU-2-W-CL2022-11-16
07540299000013AnchorKnot SutureASU-0-WB-CL2022-11-16
07540299000075AnchorKnot SutureASU-0-WB-LR2022-11-16
07540299000082AnchorKnot SutureASU-0-W-LR2022-11-16
07540299000099AnchorKnot SutureASU-2-0-WB-LR2022-11-16
07540299000105AnchorKnot SutureASU-2-0-W-LR2022-11-16
07540299000112AnchorKnot SutureASU-2-WB-LR2022-11-16
07540299000129AnchorKnot SutureASU-2-W-LR2022-11-16
07540299000136AnchorKnot Suture Passer (2-0) PSZ-400-3052022-11-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B382SD89519020Surgical DirectSurgical Direct, Inc.GEI2026-11-03
SD89839030Surgical DirectSurgical Direct, Inc.GEI2026-11-03
03830066950271GREEN IRFIskra Medical, d.o.o.GEI2026-11-02
00199150071999MedtronicMEDTRONIC NAVIGATION, INC.GEI2026-11-01
00810026184093Bipolar ForcepsSONIQUENCE, LLCGEI2026-11-01
00841019124147KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-31
04953170467875THUNDERBEAT 5 mm,35 cm, Front-actuated Grip Type SOLYMPUS MEDICAL SYSTEMS CORP.GEI2026-10-29
04953170467882THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type SOLYMPUS MEDICAL SYSTEMS CORP.GEI2026-10-29
00841019124178KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-28
00841019124161KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-27
00841019124239KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-27
00190776439774MilleniumAvalign Technologies, Inc.GEI2026-10-26
10884521783829LigaSureCovidien LPGEI2026-10-23
00190776436858MillenniumAvalign Technologies, Inc.GEI2026-10-22
B382SD77105560Surgical DirectSurgical Direct, Inc.GEI2026-10-22
00190776435752MillenniumAvalign Technologies, Inc.GEI2026-10-21
00190776435769MillenniumAvalign Technologies, Inc.GEI2026-10-21
00841019124192KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-21
B108499AP1MRA1MUS00Large applicatorBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499AP1MRA2MUS00Small applicatorBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499AP1MRA45MUS00Edge applicatorsBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499PO1MUS00BTL-499-1BTL INDUSTRIES LIMITEDGEI2026-10-20
00190776435288MillenniumAvalign Technologies, Inc.GEI2026-10-19
B354OSCVORTH80Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH81Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH82Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH83Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH84Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19