FDA UDI
In Commercial Distribution
🇺🇸 United States
ISSA™ Pro Set
DI: 07350071075500
·
Model: LAVENDER
·
Foreo AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ISSA™ Pro Set
- Primary DI
- 07350071075500
- Version / Model
- LAVENDER
- Company Name
- Foreo AB
- Labeler DUNS
- 352394143
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-26
- Public Version
- 1
- Public Version Date
- 2022-06-03
- Public Version Status
- New
- Public Device Record Key
- fc401e12-eee7-4906-a358-90ebb9164afd
Device Description
FOREO's ISSA™ Pro helps you to achieve a brighter and whiter smile, whilst maintaining healthy gums and protecting from gum recession. Featuring soft, gentle silicone bristles that resist bacteria build-up and channel 183 high-intensity pulsations per second, the toothbrush cleans the teeth and gums to removes plaque and prevent cavities, without scratching tooth enamel or damaging gums. Fully waterproof and ultra-hygienic, the sleek, ergonomic ISSA™ has eight speed settings to suit individual needs and a 3D flexible brush head to reach every area of the mouth. Each 1 hour USB charge lasts up to 365 uses.
Device Characteristics
- Single Use
- No
- 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
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 43090 | Basic electric toothbrush | An electrically-powered device designed to be used by a patient to brush clean their teeth and gums (i.e., remove plaque, tartar, stains). It typically consists of a proximal handle and an exchangeable distal head with rows of bristles (e.g., nylon) grouped in separate tufts or evenly distributed. The device provides automated bristle movement (e.g., rotary or vibratory) intended to augment brushing, and is typically used with toothpaste. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07350071075500 | GS1 |