FDA UDI
In Commercial Distribution
🇺🇸 United States
SmileGoods Giraffe Flossers Trial Packs
DI: 00723896008805
·
Model: 7109859
·
PRACTICON, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
144
Basic Information
- Brand Name
- SmileGoods Giraffe Flossers Trial Packs
- Primary DI
- 00723896008805
- Version / Model
- 7109859
- Catalog Number
- 71-09859
- Company Name
- PRACTICON, INC.
- Labeler DUNS
- 119193803
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 144
- Record Status
- Published
- Publish Date
- 2018-07-19
- Public Version
- 1
- Public Version Date
- 2018-08-20
- Public Version Status
- New
- Public Device Record Key
- df039027-6c96-412a-816a-5ab77e7f4b2d
Device Description
make flossing more fun! Designed for kids, they feature high-quality nylon floss mounted in non-slip giraffe handles. 2-7/8" long. Four flossers per pack in assorted colors, 144 packs per box. Not for children under 3 years of age.
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 | 00723896008812 | GS1 | Case | 8 | In Commercial Distribution | |
| Primary | 00723896008805 | GS1 | ||||
| Unit of Use | 00723896008799 | GS1 |