Vaginal Tactile Imager

GUDID 00864124000106

Advanced Tactile Imaging, Inc.

Pelvic floor tactile imaging system

• Primary Device ID: 00864124000106
• NIH Device Record Key: 11abcc42-d8d1-4652-9d10-05c54e653e98
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vaginal Tactile Imager
• Version Model Number: 2S
• Company DUNS: 078793844
• Company Name: Advanced Tactile Imaging, Inc.
• 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: false
• Serial Number: true
• 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	00864124000106 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142355

FDA Product Code

• HIR: Perineometer

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-03-25
• Device Publish Date: 2020-11-10