TheraBite Bite Pad, Edentulous PA002

GUDID 07331791016608

The TheraBite Bite Pads are self-adhesive pads intended to protect the user’s teeth.

Atos Medical AB

Mastication muscle exerciser

• Primary Device ID: 07331791016608
• NIH Device Record Key: c6ddb6a2-b90d-4677-a3c3-f84ca26f2e36
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TheraBite Bite Pad, Edentulous
• Version Model Number: PA002
• Catalog Number: PA002
• Company DUNS: 355470923
• Company Name: Atos Medical AB
• Device Count: 4
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com

Device Dimensions

• Width: 6 Centimeter
• Width: 6 Centimeter
• Width: 6 Centimeter
• Width: 6 Centimeter
• Width: 6 Centimeter
• Width: 6 Centimeter
• Width: 6 Centimeter
• Width: 6 Centimeter
• Width: 6 Centimeter
• Width: 6 Centimeter
• Width: 6 Centimeter
• Width: 6 Centimeter
• Width: 6 Centimeter
• Width: 6 Centimeter
• Width: 6 Centimeter
• Width: 6 Centimeter
• Width: 6 Centimeter
• Width: 6 Centimeter
• Width: 6 Centimeter
• Width: 6 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	07331791004841 [Primary]
GS1	07331791016608 [Unit of Use]

FDA Product Code

• ION: Exerciser, Non-Measuring

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: 2022-12-06
• Device Publish Date: 2022-11-28

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