Home GUDID 00841983101489 NA
Primary DI 00841983101489
Brand NA
Company NIHON KOHDEN AMERICA, INC.
Model YE-103J
Catalog number YE-103J
Device description Earphones
Published 2016-09-19
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name IKN Electromyograph, diagnostic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class IKN Electromyograph, Diagnostic Physical Medicine 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00841983101489 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00841983101489 00841983101489 841983101489 0841983101489
GMDN Terms# Term, Definition table Term Definition Evoked-potential graphic recording system An assembly of devices designed for recording a localized electrical potential from the brain or spinal cord in response to stimulation (i.e., visual, auditory, and/or somatosensory) of the sensory organs, or of some point along the ascending pathway from the sensory organs, or within the central nervous system. It typically includes a sensory stimulator/stimulation system and a graphic recorder. The characteristics of the recorded potential vary with recording location, stimulus modality and level, and level of consciousness or anaesthesia. The resultant waveform may be used to assess the function and integrity of the brain and its sensory pathways.
Regulatory Flags# DUNS number 021063219 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 20763000886794 N/a MEDTRONIC XOMED, INC. IKN 2025-06-23 10853818007504 USB C Adapter PRECISION BIOMETRICS INC IKN 2024-09-03 00853818007507 USB C to C Cable PRECISION BIOMETRICS INC IKN 2024-09-03 00195377099013 PULSE Nuvasive, Inc. IKN 2023-07-06 00190376459028 SafeOp ALPHATEC SPINE, INC. IKN 2023-02-12 00190376459042 SafeOp ALPHATEC SPINE, INC. IKN 2023-02-12 00689281035712 Invisia Shower Bench, 24", Light, Chrome Plate Healthcraft Products Inc. IKN 2022-11-17 00853818007477 MyoVision Software PRECISION BIOMETRICS INC IKN 2022-11-10 00195377049193 PULSE Nuvasive, Inc. IKN 2022-05-06 00195377058508 PULSE Nuvasive, Inc. IKN 2022-05-06 00195377060716 PULSE Nuvasive, Inc. IKN 2022-05-06 00195377061379 PULSE Nuvasive, Inc. IKN 2022-05-06 00195377065544 PULSE Nuvasive, Inc. IKN 2022-05-06 00195377081636 PULSE Nuvasive, Inc. IKN 2022-05-06 00840067103616 Cascade IOMAX CADWELL INDUSTRIES, INC. IKN 2021-10-15 00382830042369 Natus NATUS NEUROLOGY INCORPORATED IKN 2021-07-20 00887517070708 NVM5 Nuvasive, Inc. IKN 2021-06-15 00887517075383 NVM5 Nuvasive, Inc. IKN 2021-06-15 00887517091994 NVM5 Nuvasive, Inc. IKN 2021-06-15 00887517097958 NVM5 Nuvasive, Inc. IKN 2021-06-15 00887517320919 NVM5 Nuvasive, Inc. IKN 2021-06-15 00841983104251 Neuropack S3 NIHON KOHDEN AMERICA, INC. IKN 2020-07-20 00841983104268 Neuropack S3 NIHON KOHDEN AMERICA, INC. IKN 2020-07-20 00190376180359 SafeOp ALPHATEC SPINE, INC. IKN 2019-12-31 00190376192277 SafeOp ALPHATEC SPINE, INC. IKN 2019-12-31 00887517048646 NVM5 Nuvasive, Inc. IKN 2019-11-21 00887517075758 NVM5 Nuvasive, Inc. IKN 2019-11-21 00887517075772 NVM5 Nuvasive, Inc. IKN 2019-11-21 00887517090041 NVM5 Nuvasive, Inc. IKN 2019-11-21 00887517990754 PULSE Nuvasive, Inc. IKN 2019-11-18