FDA.reportPublic FDA data

EARP NERVE CUFF ELECTRODE, 5MM

Primary DI
00810161901562
Brand
EARP NERVE CUFF ELECTRODE, 5MM
Company
RETROPSOAS TECHNOLOGIES, LLC
Model
ELEC1100-05
Published
2026-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241917000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241917000EARP Nerve Cuff ElectrodeRetropsoas Technologies, LLC2024-07-31ETN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810161901562PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810161901562008101619015628101619015620810161901562

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, nerve locationA small unit dedicated to the localization of a nerve in an area of the body. It is used, e.g., in the administration of relaxants and local anaesthesia and is comprised of a nerve stimulator and a receiver which registers the activity signal of nerves. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device which then operates as a mainframe computer displaying the parameters/information measured and provided by this module.

Regulatory Flags#

DUNS number
119266920
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810161900305EARP, TRIAL 22X35X12 6°EARP-T-2235-06122026-10-16
00810161900312EARP, TRIAL 22X35X14 6°EARP-T-2235-06142026-10-16
00810161900329EARP, TRIAL 22X35X12 12°EARP-T-2235-12122026-10-16
00810161900336EARP, TRIAL 22X35X14 12°EARP-T-2235-12142026-10-16
00810161900381EARP, 14X25X08 0°EARP1425-00082026-10-16
00810161900398EARP, 14X25X10 6°EARP1425-06102026-10-16
00810161900404EARP, 14X25X12 6°EARP1425-06122026-10-16
00810161900411EARP, 14X25X12 12°EARP1425-12122026-10-16
00810161900428EARP, 14X30X08 0°EARP1430-00082026-10-16
00810161900435EARP, 14X30X10 6°EARP1430-06102026-10-16
00810161900442EARP, 14X30X12 6°EARP1430-06122026-10-16
00810161900459EARP, 14X30X12 12°EARP1430-12122026-10-16
00810161900466EARP, 14X35X08 0°EARP1435-00082026-10-16
00810161900473EARP, 14X35X10 6°EARP1435-06102026-10-16
00810161900480EARP, 14X35X12 6°EARP1435-06122026-10-16
00810161900497EARP, 14X35X12 12°EARP1435-12122026-10-16
00810161900503EARP, 14X40X10 6°EARP1440-06102026-10-16
00810161900510EARP, 14X40X12 6°EARP1440-06122026-10-16
00810161900527EARP, 14X40X12 12°EARP1440-12122026-10-16
00810161900534EARP, 18X30X08 0°EARP1830-00082026-10-16

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Primary DI, Brand, Company table
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00860010951705NeuralytixNEURALYTIX, LLCETN2026-10-19
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00810161901579EARP NERVE CUFF ELECTRODE, 6MM (Sterile)RETROPSOAS TECHNOLOGIES, LLCETN2026-10-15
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04250307613526N/Ainomed Medizintechnik GmbHETN2026-10-01
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