FDA UDI
In Commercial Distribution
🇺🇸 United States
TheraBite Bite Pad, Regular
DI: 07331791004834
·
Model: PA001
·
Atos Medical AB
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
4
Basic Information
- Brand Name
- TheraBite Bite Pad, Regular
- Primary DI
- 07331791004834
- Version / Model
- PA001
- Catalog Number
- PA001
- Company Name
- Atos Medical AB
- Labeler DUNS
- 355470923
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2022-11-28
- Public Version
- 1
- Public Version Date
- 2022-12-06
- Public Version Status
- New
- Public Device Record Key
- 2c5de315-b050-48ad-b80a-d8399313248f
Device Description
The TheraBite Bite Pads are self-adhesive pads intended to protect the user’s teeth.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ION | Exerciser, Non-Measuring | Physical Medicine | 890.5370 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17802 | Mastication muscle exerciser | An intraoral mechanical exercise apparatus intended primarily to strengthen and rehabilitate the jaw muscles of mastication of a patient who has pain in, or disorders of, the temporomandibular joint (TMJ), typically through repetitive biting against resistive forces provided by the device. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 07331791016592 | GS1 | ||||
| Primary | 07331791004834 | GS1 |
Customer Contacts
- Phone
- +4641519800
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 6 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 42 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 36 – 108 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry. Keep away from sunlight