FDA UDI
In Commercial Distribution
🇺🇸 United States
SmileGoods FlosSeas Singles
DI: 00723896010525
·
Model: 70-45281
·
PRACTICON, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
200
Basic Information
- Brand Name
- SmileGoods FlosSeas Singles
- Primary DI
- 00723896010525
- Version / Model
- 70-45281
- Catalog Number
- 70-45281
- Company Name
- PRACTICON, INC.
- Labeler DUNS
- 119193803
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 200
- Record Status
- Published
- Publish Date
- 2018-07-18
- Public Version
- 1
- Public Version Date
- 2018-08-20
- Public Version Status
- New
- Public Device Record Key
- aaa06739-4cc4-47a4-b4df-97157956fea2
Device Description
By popular demand, our SmileGoods FlosSeas Flossers are now also available individually wrapped as FlosSeas Singles! FlosSeas Flossers help you introduce flossing to younger patients. Specially designed for kids, FlosSeas feature high-quality nylon floss mounted securely to prevent breakage. 2-7/8" long. Assorted bright sea animal shapes. Includes two handy dispenser boxes containing 100 individually wrapped flossers each, 200 flossers total. Not intended for children under 3 years old.
Device Characteristics
- Single Use
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| 11158 | Dental floss | A string-like device formed as thread or tape, used for the removal of plaque and/or debris from the proximal surfaces of teeth and the gingival surfaces of fixed prostheses. It is typically made of a synthetic fibre. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00723896010532 | GS1 | Case | 12 | In Commercial Distribution | |
| Primary | 00723896010525 | GS1 | ||||
| Unit of Use | 00723896001608 | GS1 |