FDA.reportPublic FDA data

BIONEN

Primary DI
08033315122688
Brand
BIONEN
Company
BIONEN SAS DI BARBARA NENCIONI & C.
Model
0028528
Device description
Hypodermic Needle Electrode for Botox injection (disposable)
Published
2018-09-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
IKTElectrode, Needle, Diagnostic Electromyograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKTElectrode, Needle, Diagnostic ElectromyographPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092973000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092973000DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLEBionen S.A.S.2010-10-07IKT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033315122688PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033315122688080333151226888033315122688

GMDN Terms#

Term, Definition table
TermDefinition
Electromyographic needle electrode, single-useA sterile electrical conducting device designed to be inserted percutaneously into muscle or nerve tissue to detect bioelectrical signal activity. It is a needle-like device (a needle electrode with an electrical connector at the proximal end) that is connected to an electromyograph (EMG) with a dedicated cable/lead. The EMG records the electrical signals and converts them into a readable graph format; it is not primarily intended for nerve stimulation. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length45Millimeter
Needle Gauge28Gauge

Regulatory Flags#

DUNS number
444022750
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08033315120394BIONEN02101002026-02-16
08033315122299BIONEN00280122018-09-04
08033315122312BIONEN00280132018-09-04
08033315122336BIONEN00280142018-09-04
08033315122350BIONEN00280152018-09-04
08033315122374BIONEN00280162018-09-04
08033315122398BIONEN00280172018-09-04
08033315122411BIONEN00280182018-09-04
08033315122442BIONEN00281122018-09-04
08033315122466BIONEN00281132018-09-04
08033315122541BIONEN00285212018-09-04
08033315122565BIONEN00285222018-09-04
08033315122589BIONEN00285232018-09-04
08033315122602BIONEN00285242018-09-04
08033315122626BIONEN00285252018-09-04
08033315122640BIONEN00285262018-09-04
08033315122664BIONEN00285272018-09-04

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08718375869154AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869185AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869215AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869246AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869277AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869604Neurosign V4Technomed Engineering B.V.IKT2022-07-04
08718375869628Neurosign V4Technomed Engineering B.V.IKT2022-07-04
08718375869871Neurosign V4Technomed Engineering B.V.IKT2022-04-14
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08718375867556Technomed EuropeTechnomed Engineering B.V.IKT2021-02-24
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