FDA.reportPublic FDA data

Regentex

Primary DI
00677346310850
Brand
Regentex
Company
PEPIN MANUFACTURING, INC.
Model
500
Device description
"2"" x 3.5"" Butterfly w/ Snap"
Published
2017-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070807000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070807000CUTANEOUS ELECTROTHERAPY AND RECORDING ELECTRODES; TENS ELECTRODESPepin Mfg., Inc.2007-05-23GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00677346320958PackageGS112In Commercial Distribution
00677346320965PackageGS130In Commercial Distribution
00677346320972PackageGS150In Commercial Distribution
00677346320989PackageGS1100In Commercial Distribution
00677346310850PrimaryGS10
00677346300837Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00677346320958006773463209586773463209580677346320958
00677346320965006773463209656773463209650677346320965
00677346320972006773463209726773463209720677346320972
00677346320989006773463209896773463209890677346320989
00677346310850006773463108506773463108500677346310850
00677346300837006773463008376773463008370677346300837

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation electrode, single-useAn electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-use device.

Regulatory Flags#

DUNS number
807703996
Device count
2
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00677346310898AdvanTrode20-05212024-10-04
00677346310904AdvanTrode20-05402024-10-04
00677346300875AdvanTrode20-05212024-10-04
00677346300882AdvanTrode20-05402024-10-04
00677346310812AdvanTrode20-05712017-01-19
00677346310881AdvanTrodeWH112023-12-14
00677346300868AdvanTrodeWH112023-12-14
00677346310010AdvanTrodeWF12016-10-05
00677346310027AdvanTrodeWF3752016-10-05
00677346310034AdvanTrodeSF3752016-10-05
00677346310041AdvanTrodeWF22016-10-05
00677346310058AdvanTrodeWF222016-10-05
00677346310065AdvanTrodeWF125o2016-10-05
00677346310072AdvanTrodeWF24o2016-10-05
00677346310089AdvanTrodeWF132016-10-05
00677346310096AdvanTrodeWF32016-10-05
00677346310102AdvanTrodeWF352016-10-05
00677346310119AdvanTrodeWTS152016-10-05
00677346310126AdvanTrodeWTS22016-10-05
00677346310133AdvanTrodeWTS222016-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810200390265KSK.S. CHOI, CORPORATIONGXY2026-09-22
00810200390272AcuZoneK.S. CHOI, CORPORATIONGXY2026-09-22
00860014334320PASCALL SYSTEMS, INC.PASCALL SYSTEMS, INC.GXY2026-09-04
08720791379131EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379148EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379155EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379162EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379179EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379209EZ1020Technomed Engineering B.V.GXY2026-08-07
00850080988640AUVONUAN HEALTHCARE LIMITEDGXY2026-07-22
00850080988633AUVONUAN HEALTHCARE LIMITEDGXY2026-07-17
00850080988602AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850080988619AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850080988626AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850053287411ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287428ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287442ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287459ReCureNiche Biomedical, Inc.GXY2026-07-14
00850080988589AUVONUAN HEALTHCARE LIMITEDGXY2026-07-14
06971292004318AUVONShenzhen Yuwen E-Commerce Co., Ltd.GXY2026-07-13
08682250582004Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
08682250582011Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
08720791378172Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378189Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378196Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378202Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378219Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378226Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378233Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378240Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08