FDA.reportPublic FDA data

Neurosign V4

Primary DI
08718375865989
Brand
Neurosign V4
Company
Technomed Engineering B.V.
Model
4016-00
Device description
Diposable Curved Needles, 167mm stimulating electrode and 14mm x 0,38mm needle electrode
Published
2018-03-28
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
ETNStimulator, Nerve

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETNStimulator, NerveEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08718375865989PackageGS110In Commercial Distribution
08718375865972PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08718375865989087183758659898718375865989
08718375865972087183758659728718375865972

GMDN Terms#

Term, Definition table
TermDefinition
Nerve-locating system probe, single-useA hand-held surgical instrument intended to function as an electrical conductor to locate a nerve during open surgery, and for diagnostic purposes [electromyography (EMG), cortical mapping], by delivering controlled electrical impulses to a specific body site for the measurement of a neural response. It may be in the form of a needle probe or surgical forceps which is attached to an electrical pulse generator. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+31434086868info@technomed.nl

Regulatory Flags#

DUNS number
418415568
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
08718375867037Cadwell302296-000-0202020-11-13
08720791378165NeurosignNM-Kit 22026-04-30
08720791378790Technomed Europe8735-00502026-04-30
08720791378806Technomed Europe8735-00602026-04-30
08720791378813Technomed EuropeTE/Q96-8322026-04-30
08720791378837Technomed EuropeBTP2.3-160/12026-04-30
08720791378868Technomed EuropeTE/S50722-003-K2026-04-30
08720791378059Technomed EuropeTE/B50700-0012026-04-29
08720791378073Technomed EuropeTE/B50700-0022026-04-29
08720791378097Technomed EuropeTE/B50700-0062026-04-29
08720791378110Technomed EuropeTE/B50700-0032026-04-29
08720791378134Technomed EuropeTE/B50700-0042026-04-29
08720791378158Technomed EuropeTE/B50700-0052026-04-29
08720791379100Neuralytix NTX-90092026-04-28
08720791377700Inomed5256202025-12-10
08720791377717Inomed5256212025-12-10
08720791377724Inomed5256222025-12-10
08720791377731Inomed5256232025-12-10
08720791377847Inomed5200482025-12-10
08720791378530Cadwell302882-0002025-12-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20199150023862N/AMEDTRONIC XOMED, INC.ETN2026-02-16
20199150023879N/AMEDTRONIC XOMED, INC.ETN2026-02-16
20199150023886N/AMEDTRONIC XOMED, INC.ETN2026-02-16
B006NVHS102NONENeurovision Medical Products, Inc.ETN2025-12-18
B006HGELS102NONENeurovision Medical Products, Inc.ETN2025-02-12
B006NVPS2Nerveäna+®Neurovision Medical Products, Inc.ETN2025-02-11
20763000842547Bipolar Stimulating ProbeMEDTRONIC XOMED, INC.ETN2024-10-26
20763000842554Bipolar Stimulating ProbeMEDTRONIC XOMED, INC.ETN2024-10-26
20763000842561Bipolar Stimulating ProbeMEDTRONIC XOMED, INC.ETN2024-10-26
10887482176853BovieASPEN SURGICAL PRODUCTS, INC.ETN2024-08-27
08720791376451Technomed EuropeTechnomed Engineering B.V.ETN2024-05-06
08720791376475Technomed EuropeTechnomed Engineering B.V.ETN2024-05-06
08720791376482Technomed EuropeTechnomed Engineering B.V.ETN2024-05-06
08720791373634NeuroradiumTechnomed Engineering B.V.ETN2024-02-12
08720791373665NeuroradiumTechnomed Engineering B.V.ETN2024-02-12
B006NVPTKITC3P6WSF52Nerveana+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPTKITC3P7WSF52Nerveana+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPTKITC3P8WSF52Nerveana+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPTKITDCLD52Nerveana+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPTKITDCLWF52Nerveäna+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPTKITDCSD52Nerveana+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPTKITDCSWF52Nerveäna+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPMK1Nerveäna+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPSTST2Nerveäna+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPT1Nerveäna+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPUSB1Nerveäna+®Neurovision Medical Products, Inc.ETN2024-02-01
B006IDKWSF51252ScorpionNeurovision Medical Products, Inc.ETN2023-09-01
B006NVPTKITC3P652Nerveana+®Neurovision Medical Products, Inc.ETN2023-04-20
B006NVPTKITC3P6T52Nerveana+®Neurovision Medical Products, Inc.ETN2023-04-20
B006NVPTKITC3P752Nerveana+®Neurovision Medical Products, Inc.ETN2023-04-20