FDA.reportPublic FDA data

NA

Primary DI
00813250014303
Brand
NA
Company
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
Model
RFK-C15616S
Device description
Cannula, 15cm, 6mm tip, 16G 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
GXIPROBE, RADIOFREQUENCY LESION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXIProbe, Radiofrequency LesionNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813250014303PackageGS110In Commercial Distribution
00813250014297PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813250014303008132500143038132500143030813250014303
00813250014297008132500142978132500142970813250014297

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
14895233602366LCCSLCCS Products LimitedGXI2025-11-17
00856895008153One RF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXI2025-09-01
00856895008139One RF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXI2025-08-20
00856895008146One RF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXI2025-08-20
00852454006424IntraceptRelievant Medsystems, Inc.GXI2025-08-04
00825114014879OWLDiros Technology IncGXI2025-07-16
04048223131947RFTLPajunk GmbH MedizintechnologieGXI2025-06-17
04048223131954RFTLPajunk GmbH MedizintechnologieGXI2025-06-17
04048223132005RFTLPajunk GmbH MedizintechnologieGXI2025-06-17
04048223132340TLPajunk GmbH MedizintechnologieGXI2025-06-17
04048223132357TLPajunk GmbH MedizintechnologieGXI2025-06-17
04048223132470RFTL SonoPajunk GmbH MedizintechnologieGXI2025-06-17
04048223132647RFTLPajunk GmbH MedizintechnologieGXI2025-06-17
04048223132692RFTLPajunk GmbH MedizintechnologieGXI2025-06-17
04048223132715RFTLPajunk GmbH MedizintechnologieGXI2025-06-17
04048223049709RGNPajunk GmbH MedizintechnologieGXI2025-01-30
04048223050132RFTLPajunk GmbH MedizintechnologieGXI2025-01-30
04048223050484RFTL SonoPajunk GmbH MedizintechnologieGXI2025-01-30
00856895008634OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXI2024-12-02
00856895008641OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXI2024-12-02
00856895008658OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXI2024-12-02
40195327666355Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXI2024-11-03
M661SCV181505Radiofrequency (RF) NeedleSpectra Medical Devices, LLCGXI2024-06-18
M661SCV201005Radiofrequency (RF) NeedleSpectra Medical Devices, LLCGXI2024-06-18
M661SCV201505Radiofrequency (RF) NeedleSpectra Medical Devices, LLCGXI2024-06-18
M661SCV201510Radiofrequency (RF) NeedleSpectra Medical Devices, LLCGXI2024-06-18
M661SCV201515Radiofrequency (RF) NeedleSpectra Medical Devices, LLCGXI2024-06-18
M661SCV220505Radiofrequency (RF) NeedleSpectra Medical Devices, LLCGXI2024-06-18
M661SCV220510Radiofrequency (RF) NeedleSpectra Medical Devices, LLCGXI2024-06-18
M661SCV221005Radiofrequency (RF) NeedleSpectra Medical Devices, LLCGXI2024-06-18