FDA UDI
In Commercial Distribution
🇺🇸 United States
FlossBow Ortho Flossers
DI: 00723896010860
·
Model: 7109860
·
PRACTICON, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
200
Basic Information
- Brand Name
- FlossBow Ortho Flossers
- Primary DI
- 00723896010860
- Version / Model
- 7109860
- Catalog Number
- 71-09860
- Company Name
- PRACTICON, INC.
- Labeler DUNS
- 119193803
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 200
- 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
- 06733907-02af-4777-84c7-504819a4516b
Device Description
ur exclusive FlossBow Orthodontic Flosser is specially designed to help patients quickly and easily floss behind braces—without a threader. Floss faster and more often. Floss anywhere—on the go! Floss with one hand. With other orthodontic flossers, floss can pop loose from the thin extension. FlossBow features strong floss and secure end points to solve this problem. Plus, its double-ended design is like having two flossers in one! Ideal for both ortho and non-ortho users.
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 | 00723896010877 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 00723896010860 | GS1 | ||||
| Unit of Use | 00723896001592 | GS1 |