FDA.reportPublic FDA data

Neurosign V4

Primary DI
08718375866672
Brand
Neurosign V4
Company
Technomed Engineering B.V.
Model
BTP255-2.3-1B
Device description
Disposable XL Pedicle Screw Probe 2.3mm ball bent shaft 255x2.2mm 1pc
Published
2020-07-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXZElectrode, Needle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXZElectrode, NeedleNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08718375866665PackageGS11In Commercial Distribution
08718375866672PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08718375866665087183758666658718375866665
08718375866672087183758666728718375866672

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.

Contacts#

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

Regulatory Flags#

DUNS number
418415568
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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
08718375869062AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375869093AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375869123AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375869154AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375868102Consolidated Neuro SupplyTechnomed Engineering B.V.GXZ2021-06-02
08718375867129NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867143NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867167NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867181NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867204NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867228NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867242NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867266NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867280NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867303NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867556Technomed EuropeTechnomed Engineering B.V.GXZ2021-02-24
08718375867570Technomed EuropeTechnomed Engineering B.V.GXZ2021-02-24
08718375867884Technomed EuropeTechnomed Engineering B.V.GXZ2021-02-24
08718375867891Technomed EuropeTechnomed Engineering B.V.GXZ2021-02-24
08718375867907Technomed EuropeTechnomed Engineering B.V.GXZ2021-02-24
08718375867914Technomed EuropeTechnomed Engineering B.V.GXZ2021-02-24
08718375867921Technomed EuropeTechnomed Engineering B.V.GXZ2021-02-24
08718375867938Technomed EuropeTechnomed Engineering B.V.GXZ2021-02-24
08718375867945Technomed EuropeTechnomed Engineering B.V.GXZ2021-01-20
08718375867969Neurosign V4Technomed Engineering B.V.GXZ2021-01-12
08718375867983Neurosign V4Technomed Engineering B.V.GXZ2021-01-12
08718375867327Technomed EuropeTechnomed Engineering B.V.GXZ2020-12-08
08718375867341Technomed EuropeTechnomed Engineering B.V.GXZ2020-12-08
08718375867365Technomed EuropeTechnomed Engineering B.V.GXZ2020-12-08
08718375867785Technomed EuropeTechnomed Engineering B.V.GXZ2020-07-22