FDA.reportPublic FDA data

NA

Primary DI
00813250016789
Brand
NA
Company
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
Model
RFK-C101020S-ZK
Device description
SideKick, 10cm,10mm tip,20G Sharp Curved
Published
2017-06-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GXDGENERATOR, LESION, RADIOFREQUENCY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXDGenerator, Lesion, RadiofrequencyNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813250016789PackageGS110In Commercial Distribution
00813250016741PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813250016789008132500167898132500167890813250016789
00813250016741008132500167418132500167410813250016741

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency ablation systemAn assembly of devices designed to generate and apply radio-frequency (RF) electrical current for heating via an electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues, including nerves, tumours, precancerous tissue; it may be intended for coagulation however it is not intended for electrosurgical cutting. It typically includes a mains electricity (AC-powered) RF current generator, controls, cables, and an appropriate electrosurgical ablation probe, catheter, and/or handpiece with electrode(s).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
824951958
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08714729121466Precision™SC-43002015-11-09
08714729121473Precision™SC-43052015-11-09
08714729121480Precision™SC-43102015-11-09
08714729767572Precision ™SC-42302015-11-09
08714729767626Precision™SC-43062015-11-09
08714729767756Precision™SC-43012015-11-09
08714729767763Precision™SC-43112015-11-09
08714729905318Clik™ XSC-4318SC-43182015-09-29
08714729905325Clik™ X MRISC-43192016-05-03
08714729907091Precision Montage™SC-10202016-05-03
08714729931775Freelink™SC-5250R2016-05-03
00191506048464GX1™RFG-X1-120VRFG-X1-120V2025-09-29
00191506048518GX1™RFG-X1-220VRFG-X1-220V2025-09-29
00191506048563GX1™RFG-X1-240VRFG-X1-240V2025-09-29
00191506059309GX1™GX1-SYS-ROWGX1-SYS-ROW2025-09-29
00191506059330GX1™51779845-0151779845-012025-09-29
00191506059347GX1™51779845-0251779845-022025-09-29
00191506059354GX1™51779845-0351779845-032025-09-29
08714729951254Spectra WaveWriter™SC-11602017-06-05
08714729952046Spectra WaveWriter™SC-51602017-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00191506048464GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXD2025-09-29
00191506048518GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXD2025-09-29
00191506048563GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXD2025-09-29
00191506059309GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXD2025-09-29
00191506059330GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXD2025-09-29
00191506059347GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXD2025-09-29
00191506059354GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXD2025-09-29
05415067049650NAST. JUDE MEDICAL, INC.GXD2024-03-26
00856895008498OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXD2024-03-15
00856895008504OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXD2024-03-15
00856895008511OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXD2024-03-15
00856895008528OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXD2024-03-15
00856895008535OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXD2024-03-15
00856895008559OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXD2024-03-15
00856895008566OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXD2024-03-15
40195327563425Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXD2024-03-03
15415067034516N/AST. JUDE MEDICAL, INC.GXD2023-10-25
00825114000032OWLDiros Technology IncGXD2023-06-19
00852454006288RelievantRELIEVANT MEDSYSTEMS, INC.GXD2022-12-09
00193493000692COOLIEF*Avanos Medical, Inc.GXD2022-10-17
00193493000340AVANOSAvanos Medical, Inc.GXD2021-03-03
00193493000357AVANOSAvanos Medical, Inc.GXD2021-03-03
00193493000401AVANOSAvanos Medical, Inc.GXD2021-01-27
00193493000418AVANOSAvanos Medical, Inc.GXD2021-01-27
00193493473021COOLIEF*Avanos Medical, Inc.GXD2021-01-27
00193493473038COOLIEF*Avanos Medical, Inc.GXD2021-01-27
05415067029317IonicRF™ST. JUDE MEDICAL, INC.GXD2020-12-14
05415067033833IonicRF™ST. JUDE MEDICAL, INC.GXD2020-12-11
00193493473014AVANOSAvanos Medical, Inc.GXD2020-10-16
00193493473052AVANOSAvanos Medical, Inc.GXD2020-10-16