FDA.reportPublic FDA data

NeuroTherm™

Primary DI
15415067022360
Brand
NeuroTherm™
Company
NEUROTHERM, INC.
Model
RFDEUK-20
Catalog number
RFDEUK-20
Published
2015-10-30
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

Contact Domains#

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
15415067022360PackageGS110In Commercial Distribution
05415067022363PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1541506702236015415067022360
05415067022363054150670223635415067022363

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency ablation system probe, single-useA sterile, semi-flexible, hand-held surgical instrument designed to connect to a radio-frequency (RF) ablation system generator to deliver RF energy to a targeted operative site for soft-tissue ablation (i.e., thermal ablation, therapeutic lesion, or denervation). It includes multiple monopolar electrodes that extend from its tip, once deployed, for application to the treatment site; the electrodes typically include temperature-sensing elements. The device is intended to be used in percutaneous, laparoscopic, or open surgery procedures to ablate tissue typically in the brain/nerves, liver, and/or in small or metastatic tumours. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length20Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool dry place; avoid exposure to extreme temperatures.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
124023552
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
true
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
05415067021243NeuroTherm™AC-B-DUKAC-B-DUK2015-12-18
05415067021274NeuroTherm™AC-POLE-NTAC-POLE-NT2015-12-18
05415067021342NeuroTherm™AC-IDET-8AC-IDET-82015-12-18
05415067022936NeuroTherm™S-1010-B-18S-1010-B-182015-09-14
05415067022943NeuroTherm™S-1510-B-18S-1510-B-182015-09-14
05415067021922NeuroTherm™CLASSICS-1520-RP2015-09-14
05415067021939NeuroTherm™CLASSICS-2020-RP2015-09-14
05415067022295NeuroTherm™CLASSICC-1010-B2015-09-14
05415067022448NeuroTherm™CLASSICS-1510-182015-09-14
05415067026576NeuroTherm™PT-KIT-SPT-KIT-S2016-09-12
05415067021571NeuroTherm™RFDE-10RFDE-102015-10-30
05415067021588NeuroTherm™RFDE-15RFDE-152015-10-30
05415067022349NeuroTherm™RFDEUK-15RFDEUK-152015-10-30
05415067022363NeuroTherm™RFDEUK-20RFDEUK-202015-10-30
05415067022394NeuroTherm™RFDEUK-5RFDEUK-52015-10-30
05415067021137NeuroTherm™NRFE-10NRFE-102015-10-30
05415067021144NeuroTherm™NRFE-15NRFE-152015-10-30
05415067021151NeuroTherm™NRFE-5NRFE-52015-10-30
05415067021595NeuroTherm™RFDE-5RFDE-52015-10-30
05415067021168NeuroTherm™RFE-10RFE-102015-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884450452346ViaVerte™Merit Medical Systems, Inc.GXI2026-05-19
07613327601121OptaBlateSTRYKER CORPORATIONGXI2025-05-27
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10195327666354Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXI2024-11-03
M661SST221505Radiofrequency (RF) NeedleSpectra Medical Devices, LLCGXI2024-06-18
10195327493172Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXI2024-01-07
10195327493189Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXI2024-01-07
10195327493202Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXI2024-01-07
20763000835631AccurianMEDTRONIC SOFAMOR DANEK, INC.GXI2023-09-25
20763000835648AccurianMEDTRONIC SOFAMOR DANEK, INC.GXI2023-09-25
20763000835655AccurianMEDTRONIC SOFAMOR DANEK, INC.GXI2023-09-25
10195327047030Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXI2022-08-04
00193493000265COOLIEF*Avanos Medical, Inc.GXI2022-03-17
00193493000272COOLIEF*Avanos Medical, Inc.GXI2022-03-17
00193493000296AVANOS*Avanos Medical, Inc.GXI2022-03-12
00193493000302AVANOS*Avanos Medical, Inc.GXI2022-03-12
00193493000326COOLIEF*Avanos Medical, Inc.GXI2022-03-12
00193493985920AVANOS*Avanos Medical, Inc.GXI2022-03-12
00191506013097SideKick™ 2BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXI2021-04-28
00191506013103SideKick™ 2BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXI2021-04-28
00191506013110SideKick™ 2BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXI2021-04-28
00191506013127SideKick™ 2BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXI2021-04-28
00193493000159AVANOSAvanos Medical, Inc.GXI2021-03-11
00193493000166AVANOSAvanos Medical, Inc.GXI2021-03-11
00193493000173AVANOSAvanos Medical, Inc.GXI2021-03-11
00193493000197AVANOSAvanos Medical, Inc.GXI2021-03-11
00193493000203AVANOSAvanos Medical, Inc.GXI2021-03-11
00193493478804AVANOSAvanos Medical, Inc.GXI2021-03-11
00193493478811AVANOSAvanos Medical, Inc.GXI2021-03-11
00193493478828AVANOSAvanos Medical, Inc.GXI2021-03-11