FDA.reportPublic FDA data

Urostym

Primary DI
00627825006019
Brand
Urostym
Company
Laborie Medical Technologies Canada ULC
Model
PRO180
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HIRPERINEOMETER
KPISTIMULATOR, ELECTRICAL, NON-IMPLANTABLE, FOR INCONTINENCE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIRPerineometerObstetrics/Gynecology2
KPIStimulator, Electrical, Non-Implantable, For IncontinenceGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00627825006019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00627825006019006278250060196278250060190627825006019

GMDN Terms#

Term, Definition table
TermDefinition
Biofeedback systemAn assembly of devices intended to provide visual and/or auditory signals corresponding to the status of one or more of a patient's physiological functions, e.g., brain wave activity, muscle activity, blood pressure, skin temperature, balance, so that the patient can develop some degree of conscious control over a usually involuntarily function. This system will detect changes in the physiological functions that are outside of the normal awareness, amplify these signals, and provide this as feedback to the patient. It is used in, e.g., tension headache control, muscle relaxation, rehabilitation/training, behavioural research.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
203383526
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00627825000031Pump Tubing Infusion LineTUB5002016-09-21
00627825011013Probe, Manometry, Vaginal SensorPRB1132017-09-01
00627825011020Probe, Manometry, Anal SensorPRB1082017-09-01
00627825011037Tube for Anal Sensor, with 3-way StopcockPRB0782017-09-01
00627825011044Tube for Vaginal Sensor, with 3-way StopcockPRB0802017-09-01
00627825000109ITAITA2016-09-21
00627825008204Y-Piece9021P11642016-09-21
10627825007020Extension Set 29021P12832016-09-21
10627825007297Extension Line, 60 cm9021P63122016-09-21
10627825007310Extension Line, 1500mm9021P63322016-09-21
10627825007327Extension Line, 15cm9021P63512016-09-21
10627825007341Extension Line, 150cm Blue9021P63712016-09-21
10627825007358Extension Line, 150cm Yellow9021P63812016-09-21
10627825008294Extension Set 39021P12932016-09-21
10627825008386Extension Line, 90 cm9021P63222016-09-21
10627825008393Extension Line, 150cm Red9021P63612016-09-21
10627825010358Tubing, Extension Line, Clear, with Stopcock, 150 cmTUBEX1CS2017-10-01
10627825010365Tubing, Extension Line, Clear, 150 cmTUBEX1C2017-10-01
10627825010372Tubing, Extension Line, Blue for Pves, 150 cmTUBEX1B2017-10-01
10627825010389Tubing, Extension Line, Red for Pabd, 150 cmTUBEX1R2017-10-01

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Primary DI, Brand, Company table
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04719872333104LevinaZMI ELECTRONICS LTD.KPI2026-04-14
04719872333104LevinaZMI ELECTRONICS LTD.HIR2026-04-14
04719872333593LevinaZMI ELECTRONICS LTD.KPI2026-04-14
04719872333593LevinaZMI ELECTRONICS LTD.HIR2026-04-14
04719872333616LevinaZMI ELECTRONICS LTD.HIR2026-04-14
04719872333616LevinaZMI ELECTRONICS LTD.KPI2026-04-14
04719872334033LevinaZMI ELECTRONICS LTD.KPI2026-04-14
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05033435134403TensCareTENSCARE LIMITEDKPI2024-11-18
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03830054237728StarFormerFOTONA d.o.o.KPI2024-07-30
00092237626047Richmar EMG ProDrive Devilbiss HealthcareKPI2024-06-28
00092237626054Richmar EMG ProDrive Devilbiss HealthcareKPI2024-06-28
06970935830482KONMEDShenzhen Konmed Technology Co., Ltd.KPI2024-03-05
06970935830499KONMEDShenzhen Konmed Technology Co., Ltd.KPI2024-03-05
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06970935830680KONMEDShenzhen Konmed Technology Co., Ltd.KPI2024-03-05
06970935830697KONMEDShenzhen Konmed Technology Co., Ltd.KPI2024-03-05
03770014642486Hinge Health Pelvic Trainer by PerifitX6 INNOVATIONSHIR2024-01-15
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05033435135646TensCareTENSCARE LIMITEDKPI2023-10-24
04053815076711MFG-05Zimmer MedizinSysteme GmbHKPI2023-10-16