FDA.reportPublic FDA data

EARP NERVE CUFF ELECTRODE, 4MM (Sterile)

Primary DI
00810161901555
Brand
EARP NERVE CUFF ELECTRODE, 4MM (Sterile)
Company
RETROPSOAS TECHNOLOGIES, LLC
Model
ELEC1100-04
Published
2026-10-15
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
00810161901555PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810161901555008101619015558101619015550810161901555

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
00810161900015EARP DISC SPACER INSERTEREARP-DS-0022026-10-15
00810161900022EARP INITIAL INSERTEREARP-II2026-10-15
00810161900039EARP FINAL INSERTEREARP-FI2026-10-15
00810161900046RETRACTABLE OSTEOTOMEEARP-O2026-10-15
00810161900053EARP BLADE 100EARP-R_001-1002026-10-15
00810161900060EARP BLADE 110EARP-R_001-1102026-10-15
00810161900077EARP BLADE 120EARP-R_001-1202026-10-15
00810161900084EARP BLADE 130EARP-R_001-1302026-10-15
00810161900091EARP BLADE 140EARP-R_001-1402026-10-15
00810161900107EARP BLADE 150EARP-R_001-1502026-10-15
00810161900114EARP BLADE 160EARP-R_001-1602026-10-15
00810161900121EARP BLADE 170EARP-R_001-1702026-10-15
00810161900138EARP BLADE 180EARP-R_001-1802026-10-15
00810161900145EARP BLADE 190EARP-R_001-1902026-10-15
00810161900152EARP CRADLE ASSEMBLYEARP-R_0022026-10-15
00810161900169EARP RETRACTOR CONNECTOREARP-R_0032026-10-15
00810161900176EARP RETRACTOR TILT REPLACEMENTEARP-R_0042026-10-15
00810161900183EARP CUFF TRIAL 3&4MMELEC22102026-10-15
00810161900190EARP CUFF TRIAL 5&6MMELEC22202026-10-15
00810161900206EARP, TRIAL 14X25X08 0°EARP-T-1425-00082026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810161901548EARP NERVE CUFF ELECTRODE, 3MM (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
00763000843908NIM VitalMEDTRONIC XOMED, INC.ETN2026-08-22
00763000843915NIM VitalMEDTRONIC XOMED, INC.ETN2026-08-22
10840113234728BovieASPEN SURGICAL PRODUCTS, INC.ETN2026-08-17
00887517127693MaXcessNuvasive, Inc.ETN2026-07-27
00763000821777NIM EssenceMEDTRONIC XOMED, INC.ETN2026-06-07
00763000821784NIM EssenceMEDTRONIC XOMED, INC.ETN2026-06-07
00763000821791NIM EssenceMEDTRONIC XOMED, INC.ETN2026-06-07
00763000821807NIM EssenceMEDTRONIC XOMED, INC.ETN2026-06-07
00763000821814NIM EssenceMEDTRONIC XOMED, INC.ETN2026-06-07
08681823002772Bioscope Neuromonitor DeviceBIOSYS BIYOMEDIKAL MUHENDISLIK SANAYI VE TICARET ANONIM SIRKETIETN2026-06-03
00887517413673MAS PLIFNuvasive, Inc.ETN2026-04-25
00199150037407NIM™MEDTRONIC XOMED, INC.ETN2026-03-29
20199150023862N/AMEDTRONIC XOMED, INC.ETN2026-02-16
20199150023879N/AMEDTRONIC XOMED, INC.ETN2026-02-16
20199150023886N/AMEDTRONIC XOMED, INC.ETN2026-02-16
03662674000525PediGuard DSG ConnectSPINEGUARDETN2025-09-17
B006HGELS102NONENeurovision Medical Products, Inc.ETN2025-02-12
20763000842547Bipolar Stimulating ProbeMEDTRONIC XOMED, INC.ETN2024-10-26
20763000842554Bipolar Stimulating ProbeMEDTRONIC XOMED, INC.ETN2024-10-26
20763000842561Bipolar Stimulating ProbeMEDTRONIC XOMED, INC.ETN2024-10-26
10887482176853BovieASPEN SURGICAL PRODUCTS, INC.ETN2024-08-27
08720791376451Technomed EuropeTechnomed Engineering B.V.ETN2024-05-06