FDA UDI
In Commercial Distribution
🇺🇸 United States
0-36 Months Brush Nylon Head For Turbo Junior and Girl Toothbrushes Regular
DI: 00810131040369
·
Model: 38000006
·
Supermouth LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- 0-36 Months Brush Nylon Head For Turbo Junior and Girl Toothbrushes Regular
- Primary DI
- 00810131040369
- Version / Model
- 38000006
- Company Name
- Supermouth LLC
- Labeler DUNS
- 049384038
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-01
- Public Version
- 1
- Public Version Date
- 2024-06-10
- Public Version Status
- New
- Public Device Record Key
- ca806235-06ff-42a0-98ef-9fc1185110b0
Device Description
Replacement Brush Head
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
- No
- 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 |
|---|---|---|---|---|
| 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 | 00810131040369 | GS1 |