Vaginal Sensor Unit TTL

GUDID 07540191000425

Technologie de Pensée Ltée

Pelvic floor muscle exerciser
Primary Device ID07540191000425
NIH Device Record Key188487d4-6c93-41d1-b523-de2f1761b7a5
Commercial Distribution StatusIn Commercial Distribution
Brand NameVaginal Sensor Unit TTL
Version Model NumberSA6050
Company DUNS209284132
Company NameTechnologie de Pensée Ltée
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107540191000425 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HIRPerineometer

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-20
Device Publish Date2017-08-31

Devices Manufactured by Technologie de Pensée Ltée

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07540191000586 - MyOnyx Mobile App2023-06-15
07540191000593 - MyOnyx 2023-06-15
07540191000623 - eVu Senz App iOS2022-05-16
07540191000609 - Pressure Sensor2022-03-31
07540191000616 - Vaginal Pressure Probe2022-03-31
07540191000555 - MyOnyx2020-07-24
07540191000562 - NEUROINFINITI 22020-07-24

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