Flyte In-Home Pelvic Floor Treatment

GUDID 00860331002018

PELVITAL USA, INC.

Perineometer Perineometer Perineometer Perineometer Perineometer Perineometer Perineometer Perineometer

• Primary Device ID: 00860331002018
• NIH Device Record Key: 9b04cb5f-a345-406c-884a-f8a1caaf8279
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flyte In-Home Pelvic Floor Treatment
• Version Model Number: MTI-1
• Company DUNS: 080346522
• Company Name: PELVITAL USA, 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860331002018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200409

FDA Product Code

• HIR: Perineometer

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-12
• Device Publish Date: 2021-08-04

On-Brand Devices [Flyte In-Home Pelvic Floor Treatment]

• 00860331002018: MTI-1
• 00860331002001: MTI-1