TheraBite Bite Pad, Regular PA001

GUDID 07331791016592

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

Atos Medical AB

Mastication muscle exerciser

Primary Device ID	07331791016592
NIH Device Record Key	2c5de315-b050-48ad-b80a-d8399313248f
Commercial Distribution Status	In Commercial Distribution
Brand Name	TheraBite Bite Pad, Regular
Version Model Number	PA001
Catalog Number	PA001
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
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
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 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
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
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	07331791004834 [Primary]
GS1	07331791016592 [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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