NeuroTherm™

Primary DI
15415067022391
Brand
NeuroTherm™
Company
NEUROTHERM, INC.
Model
RFDEUK-5
Catalog number
RFDEUK-5
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
15415067022391PackageGS110In Commercial Distribution
05415067022394PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1541506702239115415067022391
05415067022394054150670223945415067022394

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
Length5Centimeter

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

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