Flyte

GUDID 00860331002032

Flyte Gen 1.0 with small wand

PELVITAL USA, INC.

Perineometer Perineometer Perineometer Perineometer Perineometer Perineometer Perineometer Perineometer Perineometer Perineometer Perineometer Perineometer Perineometer Perineometer Perineometer Perineometer Perineometer

• Primary Device ID: 00860331002032
• NIH Device Record Key: 751d6457-5546-456e-8219-1d720307312e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flyte
• 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	00860331002032 [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: 2023-07-10
• Device Publish Date: 2023-06-30

Devices Manufactured by PELVITAL USA, INC.

• 00860331002032 - Flyte: 2023-07-10Flyte Gen 1.0 with small wand
• 00860331002032 - Flyte: 2023-07-10 Flyte Gen 1.0 with small wand
• 00860331002001 - Flyte In-Home Pelvic Floor Treatment: 2021-08-12
• 00860331002018 - Flyte In-Home Pelvic Floor Treatment: 2021-08-12