FDA.reportPublic FDA data

NA

Primary DI
07613327298024
Brand
NA
Company
Stryker Leibinger GmbH & Co. KG
Model
5140-534-620
Catalog number
5140-534-620
Device description
Paired Subdermal Electrode RD, 12x2.5mm
Published
2016-12-23
Public version status
Update
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
GWFSTIMULATOR, ELECTRICAL, EVOKED RESPONSE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWFStimulator, Electrical, Evoked ResponseNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37613327298025PackageGS110In Commercial Distribution
07613327298024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3761332729802537613327298025
07613327298024076133272980247613327298024

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length12Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00TRANSPORT: 10-90%, -20+50¿C
Storage Environment Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature4 Degrees Celsius35 Degrees Celsius

Regulatory Flags#

DUNS number
316153956
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
07613327097627CranialMask Tracker6000-390-0006000-390-0002017-03-13
07613327499711N/A8900-200-2008900-200-2002023-03-23
07613327551938N/A6002-710-0506002-710-0502022-07-26
07613327620306N/A6002-810-5006002-810-5002025-10-28
07613327616118N/A6002-810-0006002-810-0002024-08-22
07613327616255N/A6002-810-3006002-810-3002024-08-15
07613327616286N/A81-8104481-810442024-08-15
07613327638189N/A6002-810-1006002-810-1002024-08-15
07613327638196N/A6002-810-2006002-810-2002024-08-15
07613327579833N/A7000015775827000015775822024-08-07
07613327576542N/A8800-100-0008800-100-0002023-04-11
07613327500530N/A8000-060-0198000-060-0192023-03-24
07613327500615N/A8000-060-0168000-060-0162023-03-23
07613327500622N/A8000-060-0148000-060-0142023-03-23
07613327500639N/A8000-060-0158000-060-0152023-03-23
07613327500646N/A8000-060-0188000-060-0182023-03-23
07613327538328Cranial Guidance Software81-8104281-810422023-03-23
07613327538410Cranial Guidance Software6000-670-3006000-670-3002023-03-23
07613327500509N/A8000-040-0178000-040-0172023-03-22
07613327500523N/A8000-040-0188000-040-0182023-03-22

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08056446901199NExT-ASEB NEURO SPAGWF2025-05-22
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B006NVPTKITC3P8T52Nerveana+®Neurovision Medical Products, Inc.GWF2023-04-20
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