FDA.report

Neuroline InojectNeurology Needle Electrodes

Primary DI
05707480001040
Brand
Neuroline InojectNeurology Needle Electrodes
Company
Ambu A/S
Model
74450-50/10
Catalog number
74450-50/10
Device description
Needle Electrode Length: 50 mm (2") Pre-attached Leadwire: 76 cm (30") Hub Colour: Yellow
Published
2016-09-22
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

Related Records

Contact Domains

Product Codes

CodeName
IKTElectrode, needle, diagnostic electromyograph

Product Code Classifications

CodeDeviceSpecialtyClass
IKTElectrode, Needle, Diagnostic ElectromyographPhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05707480001040PackageGS116In Commercial Distribution
05707480022359PackageGS110In Commercial Distribution
05707480023844PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05707480001040057074800010405707480001040
05707480022359057074800223595707480022359
05707480023844057074800238445707480023844

GMDN Terms

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

TypeValueUnit
Length50Millimeter
Lumen/Inner Diameter0.5Millimeter

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius25 Degrees Celsius
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature10 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+14107686464Purchase_orders@ambuUSA.com
+1(410)768-6464Purchase_orders@ambuUSA.com

Regulatory Flags

DUNS number
305682023
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

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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08720791378530CadwellTechnomed Engineering B.V.IKT2025-12-10
08720791378011CadwellTechnomed Engineering B.V.IKT2025-07-16
08720791378035CadwellTechnomed Engineering B.V.IKT2025-07-15
08720791375911CadwellTechnomed Engineering B.V.IKT2025-03-12
08054655008418Disposable EMG needle electrodesSPES MEDICA SPAIKT2025-03-03
08054655023350Disposable EMG needle electrodesSPES MEDICA SPAIKT2025-03-03
08720791376642CadwellTechnomed Engineering B.V.IKT2025-02-12
08720791376680CadwellTechnomed Engineering B.V.IKT2025-02-12
08720791376727CadwellTechnomed Engineering B.V.IKT2025-02-12
08720791377861CadwellTechnomed Engineering B.V.IKT2025-01-16
08720791375232Technomed EuropeTechnomed Engineering B.V.IKT2025-01-07
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08720791375515Technomed EuropeTechnomed Engineering B.V.IKT2025-01-07
08720791377229Technomed EuropeTechnomed Engineering B.V.IKT2024-11-15
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08720791377281Technomed EuropeTechnomed Engineering B.V.IKT2024-11-15
08720791377304Technomed EuropeTechnomed Engineering B.V.IKT2024-11-15
08720791377328Technomed EuropeTechnomed Engineering B.V.IKT2024-11-15
08720791377335CadwellTechnomed Engineering B.V.IKT2024-11-15
08720791377342CadwellTechnomed Engineering B.V.IKT2024-11-15
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