Neuroline Twisted Pair SubdermalNeurology Needle E

Primary DI
05707480038732
Brand
Neuroline Twisted Pair SubdermalNeurology Needle E
Company
Ambu A/S
Model
74612-100/1/20
Catalog number
74612-100/1/20
Device description
Ambu Neuroline Twisted Part Subdermal Needle Electrode Length: 12 mm (0.5") Leadwire Length: 100 cm (40") Black is paired with 5 different colours (bl
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
05707480038732PackageGS120In Commercial Distribution
05707480038749PackageGS18In Commercial Distribution
05707480038725PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05707480038732057074800387325707480038732
05707480038749057074800387495707480038749
05707480038725057074800387255707480038725

GMDN Terms

TermDefinition
Subdermal needle electrodeA sterile, multi-purpose electrical conductor inserted beneath the dermal layer of a patient's skin to record/monitor electrical activity (biopotentials) for physiological measurements [typically electroencephalography (EEG), electromyography (EMG), and evoked-potential) and often to provide electrical stimulation. It typically consists of thin shaft of stainless steel connected to a lead wire that terminates with a safety connector for attachment to recording/monitoring and stimulation systems. This is a single-use device.

Device Sizes

TypeValueUnit
Length12Millimeter
Length100Centimeter

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius25 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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