FDA UDI
In Commercial Distribution
🇺🇸 United States
Super Vanilla Mouth Floss Fluoride
DI: 00850036799320
·
Model: 0700202001
·
Supermouth LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Super Vanilla Mouth Floss Fluoride
- Primary DI
- 00850036799320
- Version / Model
- 0700202001
- 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
- 40a71459-fce4-4bc0-ab41-fd5f8298cfba
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 |
|---|---|---|---|---|
| JES | Floss, Dental | Dental | 872.6390 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64844 | Dental floss dispenser | A manual device, similar to a bench tape dispenser, intended to be used to hold and facilitate the cutting of dental floss sections by an operator, typically with minimal contact to prevent cross-contamination; it is intended for use in a clinical setting or in the home. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850036799320 | GS1 |