FDA UDI
In Commercial Distribution
🇺🇸 United States
Aura Bright
DI: 09358910000049
·
Model: AB5
·
BRANDFARM PTY. LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Aura Bright
- Primary DI
- 09358910000049
- Version / Model
- AB5
- Company Name
- BRANDFARM PTY. LTD.
- Labeler DUNS
- 759735108
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-01
- Public Version
- 1
- Public Version Date
- 2022-04-11
- Public Version Status
- New
- Public Device Record Key
- 4dfe7f32-8e73-4e1a-9ab7-5bc477ea861e
Device Description
Aura Bright Elite Plus Sonic Toothbrush Rose Pin
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JEQ | Toothbrush, Powered | Dental | 872.6865 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63584 | Water jet flosser/sonic electric toothbrush | An electrically-powered device intended to provide a high-pressure water jet for dental flossing (removal of plaque and/or debris from between teeth) using a dedicated handpiece, and to provide (sonic) vibration for toothbrush heads attached to the handpiece for brushing the teeth. It is normally available [non-prescription] over-the-counter (OTC) fo use in the home or healthcare facility. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09358910000049 | GS1 |