FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 06970527760463
·
Model: DY-108Pro
·
Shenzhen Besman Electronic Technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 06970527760463
- Version / Model
- DY-108Pro
- Company Name
- Shenzhen Besman Electronic Technology Co., Ltd.
- Labeler DUNS
- 560455514
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-15
- Public Version
- 1
- Public Version Date
- 2023-08-23
- Public Version Status
- New
- Public Device Record Key
- 7429331b-130a-42ef-a8a2-2b15b306878c
Device Description
Electric Toothbrush
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
- Yes
- 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 |
|---|---|---|---|---|
| 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 | 06970527760463 | GS1 | ||||
| Package | 16970527760460 | GS1 | 20 | In Commercial Distribution |