FDA.report

Neuroline MonopolarNeurology Needle Electrodes

Primary DI
05707480000951
Brand
Neuroline MonopolarNeurology Needle Electrodes
Company
Ambu A/S
Model
74325-36/40
Catalog number
74325-36/40
Device description
Needle Electrode Length: 25 mm (1") Pre-attached Leadwire: 76 cm (30") Hub Colour: Dark Grey
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
GXZELECTRODE, NEEDLE

Product Code Classifications

CodeDeviceSpecialtyClass
GXZElectrode, NeedleNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05707480000951PackageGS18In Commercial Distribution
05707480022991PackageGS140In Commercial Distribution
05707480023769PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05707480000951057074800009515707480000951
05707480022991057074800229915707480022991
05707480023769057074800237695707480023769

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
Length25Centimeter
Lumen/Inner Diameter0.36Millimeter

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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