TAP 1 & 3

GUDID D84104911

TAP ORAL SLEEP APNEA DEVICE

Dyna Flex of Missouri, L.P.

Mandible-repositioning sleep-disordered breathing orthosis

• Primary Device ID: D84104911
• NIH Device Record Key: 296af74f-5986-4895-8af2-cd56dc3ffc0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TAP 1 & 3
• Version Model Number: 0491
• Company DUNS: 006335558
• Company Name: Dyna Flex of Missouri, L.P.
• 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: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• 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
HIBCC	D84104911 [Primary]

FDA Product Code

• LRK: Device, Anti-Snoring

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: 2018-03-29
• Device Publish Date: 2016-10-26

Devices Manufactured by Dyna Flex of Missouri, L.P.

• D8410056G19 - ADJUSTABLE HERBST: 2018-07-06 ORAL SLEEP APNEA APPLIANE
• D84100911Z - EZ-Align: 2018-07-06 Clear Sequential Aligner System
• D8410091L1D - EZ-Align: 2018-07-06 Sequential Aligner (Lower Tray)
• D84101101R - Dorsal Appliance: 2018-07-06 Dorsal oral sleep apnea device (Anti Snoring)
• D84101511W - LISA APPLIANCE: 2018-07-06 LISA ORAL SLEEP APNEA APPLIANCE
• D8410091U1M - EZ-Align: 2018-03-29 Orthodontic Plastic Bracket (Sequential Aligners). Upper Tray
• D84104841 - EMA APPLIANCE: 2018-03-29 EMA ORAL SLEEP APNEA APPLIANCE
• D84104911 - TAP 1 & 3: 2018-03-29TAP ORAL SLEEP APNEA DEVICE
• D84104911 - TAP 1 & 3: 2018-03-29 TAP ORAL SLEEP APNEA DEVICE