FDA.reportPublic FDA data

NeuroTherm™

Primary DI
05415067021175
Brand
NeuroTherm™
Company
NEUROTHERM, INC.
Model
RFE-10-S
Catalog number
RFE-10-S
Device description
Reusable Radiofrequency Electrode
Published
2015-10-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
05415067021175PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067021175054150670211755415067021175

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency ablation system probe, reusableA hand-held surgical device designed to connect to a radio-frequency ablation system generator to deliver radio-frequency (RF) energy to a targeted operative site for soft-tissue coagulation/ablation (i.e., thermal ablation, therapeutic lesion, or denervation). It is intended to be used in percutaneous, laparoscopic, or intraoperative procedures to ablate tissue typically in the brain/nerves, kidney, liver, and/or in small or metastatic tumours. The device typically includes multiple electrodes that extend from its tip, once deployed, and which cover the site to be treated. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10Centimeter

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
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
124023552
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

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

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Primary DI, Brand, Company table
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10195327666354Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXI2024-11-03
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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
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00191506013110SideKick™ 2BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXI2021-04-28
00191506013127SideKick™ 2BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXI2021-04-28
00193493000159AVANOSAvanos Medical, Inc.GXI2021-03-11
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00193493000203AVANOSAvanos Medical, Inc.GXI2021-03-11
00193493478804AVANOSAvanos Medical, Inc.GXI2021-03-11
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