FDA UDI
In Commercial Distribution
🇺🇸 United States
ISSA™ mini 2 Sensitive
DI: 07350092133647
·
Model: WILD STRAWBERRY
·
Foreo AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ISSA™ mini 2 Sensitive
- Primary DI
- 07350092133647
- Version / Model
- WILD STRAWBERRY
- 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
- 3b2a5b27-47ee-42f0-9c14-62a6cbfdb8a7
Device Description
ISSA™ mini 2 Sensitive is a crazy soft, super-comfortable petite powered toothbrush. In addition to the brush head made 100% out of super-soft, ultra-hygienic silicone, the cleanest, softest toothbrush also has a smaller brush head fit for young brushers or adults who prefer a smaller brush surface and was created for those with sensitive gums. Brighten, whiten and polish without damaging the tooth enamel or irritating the gum tissue and enjoy your feather-soft brush head for up to a full year of smiles.
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 | 07350092133647 | GS1 |