Vaginal Stim Sensor

GUDID 07540191000418

Technologie de Pensée Ltée

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• Primary Device ID: 07540191000418
• NIH Device Record Key: 45600f79-2aa7-4ea7-aed8-65d2198c203c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vaginal Stim Sensor
• Version Model Number: SA9572
• Company DUNS: 209284132
• Company Name: Technologie de Pensée Ltée
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540191000418 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053434

FDA Product Code

• HCC: Device, Biofeedback

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-11-20
• Device Publish Date: 2017-08-31

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• 07540191000609 - Pressure Sensor: 2022-03-31
• 07540191000616 - Vaginal Pressure Probe: 2022-03-31
• 07540191000555 - MyOnyx: 2020-07-24
• 07540191000562 - NEUROINFINITI 2: 2020-07-24