FDA.reportPublic FDA data

N/A

Primary DI
80092237617386
Brand
N/A
Company
Roscoe Medical
Model
WQ8110
Device description
CX4 & EX4 Clinical Leadwires
Published
2016-10-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
IKDCable, Electrode

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKDCable, ElectrodePhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
80092237617386PackageGS1500Not in Commercial Distribution
00092237617380PrimaryGS10
01092237617389Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
8009223761738680092237617386
00092237617380000922376173800922376173800092237617380
01092237617389010922376173891092237617389

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation leadA non-sterile, insulated, electrical conducting wire intended to be used to connect a transcutaneous electrical stimulation electrode to an electrical stimulus generator (e.g., TENS system generator), or a wire having a distal end that splits and terminates as electrodes which are placed on the patient for the transmission of electrical stimulation. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
440-572-1962CustomerService@compasshealthbrands.com
800-376-7263customerservice@compasshealthbrands.com

Regulatory Flags#

DUNS number
022542271
Device count
2
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
80092237604225Wheelchair Foam Cushion - 22 x 18 x 3WCBF-22832020-11-11
80092237604232Wheelchair Foam Cushion - 24 x 18 x 3WCBF-24832020-11-11
80092237604300Wheelchair Back Cushion Foam - 16 x 17BKF-16172020-11-11
80092237604317Wheelchair Back Cushion Foam - 18 x 17BKF-18172020-11-11
80092237604324Wheelchair Back Cushion Foam - 20 x 19BKF-20192020-11-11
80092237604331Wheelchair Back Cushion Foam - 22 x 19BKFB-22192020-11-11
80092237604270Coccyx Cushion Memory Foam - 18 x 16 x 3COC-182020-11-11
80092237605468N/ADQ78442016-10-12
80092237611629N/ADQ84502016-10-12
80092237616655N/ADE75022016-10-12
80092237616686N/ADI47382016-10-12
80092237616709N/ADI81952016-10-12
80092237616754N/ADS22022016-10-12
80092237616761N/ADS50022016-10-12
80092237617515N/ADI37172016-10-12
80813520010772N/ADT30022016-10-12
80813520011939N/ADI10102016-10-12
80092237616440N/ADQ8000W52016-10-12
60092237603118Roscoe Medical500402016-10-05
80092237603181Roscoe Medical500182016-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06978035540010SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
06978035540027SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
06978035540034SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
06978035540041SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
06978035540058SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
06978035540065SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
00850087490122AUVONChangsha Yuhong Trading Co., LtdIKD2026-06-08
00850087490146AUVONChangsha Yuhong Trading Co., LtdIKD2026-06-08
06978035540003SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-05
00650551006602PMT CORPORATIONPMT CORPORATIONIKD2026-06-01
00650551006619PMT CORPORATIONPMT CORPORATIONIKD2026-06-01
00650551006626PMT CORPORATIONPMT CORPORATIONIKD2026-06-01
04250307612871Adapter cable touchproof for ALM Tubeinomed Medizintechnik GmbHIKD2026-05-29
04250307612888Connection cable for ALM Tubeinomed Medizintechnik GmbHIKD2026-05-29
07613327688788N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.IKD2026-04-06
07613327643237N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.IKD2024-08-08
07613327643244N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.IKD2024-08-08
03664539003559NADIXI MEDICALIKD2022-07-06
03664539003566NADIXI MEDICALIKD2022-07-06
03664539003573NADIXI MEDICALIKD2022-07-06
03664539003580NADIXI MEDICALIKD2022-07-06
03664539003603NADIXI MEDICALIKD2022-07-06
03664539003610NADIXI MEDICALIKD2022-07-06
03664539003627NADIXI MEDICALIKD2022-07-06
03664539003634NADIXI MEDICALIKD2022-07-06
08033695721525NAFIAB SPAIKD2021-07-08
08033695726278NAFIAB SPAIKD2020-06-13
08033695726995NAFIAB SPAIKD2020-06-13
08054242441734NAFIAB SPAIKD2020-06-13
08054953345864NAFIAB SPAIKD2020-06-13