FDA.reportPublic FDA data

NA

Primary DI
07613327292176
Brand
NA
Company
Stryker Leibinger GmbH & Co. KG
Model
5140-530-655
Catalog number
5140-530-655
Device description
Laryngeal Electrode, ID 6-7mm
Published
2016-12-22
Public version status
Update
Distribution status
Not 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
ETNSTIMULATOR, NERVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETNStimulator, NerveEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37613327292177PackageGS110Not in Commercial Distribution
07613327292176PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3761332729217737613327292177
07613327292176076133272921767613327292176

GMDN Terms#

Term, Definition table
TermDefinition
Nerve-locating system probe, single-useA hand-held surgical instrument intended to function as an electrical conductor to locate a nerve during open surgery, and for diagnostic purposes [electromyography (EMG), cortical mapping], by delivering controlled electrical impulses to a specific body site for the measurement of a neural response. It may be in the form of a needle probe or surgical forceps which is attached to an electrical pulse generator. This is a single-use device.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
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
07613252286578FLUOROMAP6006-600-0006006-600-0002025-01-28
07613327542202N/A81-8007081-800702023-05-11
07613327542219N/A6003-700-3006003-700-3002023-05-11
07613327542363N/A6003-710-3006003-710-3002023-05-11
07613327542370N/A81-8007181-800712023-05-11
07613327542875N/A6007-700-3006007-700-3002023-05-11
07613327542998N/A81-8007281-800722023-05-11
04546540505712NA6004-650-0006004-650-0002016-08-24
04546540651600ORTHOMAP6005-660-0006005-660-0002016-08-24
04546540651624ORTHOMAP6005-661-0006005-661-0002016-08-24
07613154637164NA6004-650-3006004-650-3002016-08-24
07613252127413ORTHOMAP6005-660-3006005-660-3002016-08-24
07613252355717ORTHOMAP81-8005081-800502016-08-24
07613252433521ORTHOMAP6003-672-1006003-672-1002016-08-24
07613252433538ORTHOMAP6003-672-3006003-672-3002016-08-24
07613252448761ORTHOMAP6003-655-3006003-655-3002017-12-12
07613252448778ORTHOMAP6003-655-1006003-655-1002017-12-12
07613252449089ORTHOMAP81-8005581-800552017-12-12
04546540678683NGENIUS6003-034-0006003-034-0002016-08-24
04546540391735NA6007-425-0006007-425-0002017-12-12

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860010951705NeuralytixNEURALYTIX, LLCETN2026-10-19
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00810161901548EARP NERVE CUFF ELECTRODE, 3MM (Sterile)RETROPSOAS TECHNOLOGIES, LLCETN2026-10-15
00810161901555EARP NERVE CUFF ELECTRODE, 4MM (Sterile)RETROPSOAS TECHNOLOGIES, LLCETN2026-10-15
00810161901579EARP NERVE CUFF ELECTRODE, 6MM (Sterile)RETROPSOAS TECHNOLOGIES, LLCETN2026-10-15
04250307604388N/Ainomed Medizintechnik GmbHETN2026-10-01
04250307604425N/Ainomed Medizintechnik GmbHETN2026-10-01
04250307604449N/Ainomed Medizintechnik GmbHETN2026-10-01
04250307613526N/Ainomed Medizintechnik GmbHETN2026-10-01
04250307613533N/Ainomed Medizintechnik GmbHETN2026-10-01
04250307613540N/Ainomed Medizintechnik GmbHETN2026-10-01
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