FDA UDI
In Commercial Distribution
🇺🇸 United States
Ultimate Flosser (White Fork/White Body)
DI: D876222170
·
Model: 22217
·
ALMORE INTERNATIONAL INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Ultimate Flosser (White Fork/White Body)
- Primary DI
- D876222170
- Version / Model
- 22217
- Catalog Number
- 22217
- Company Name
- ALMORE INTERNATIONAL INC
- Labeler DUNS
- 009051723
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-26
- Public Version
- 1
- Public Version Date
- 2019-08-05
- Public Version Status
- New
- Public Device Record Key
- 0858bef4-2cb7-4319-a427-ed4de05f7898
Device Description
This easy to use flosser is ideal for people of all ages. Virtually eliminates the difficulty and finger pain associated with the common method of flossing. Makes flossing fun and promotes good oral hygiene. Simply wind the floss into place and begin flossing. The floss is advanced at the push of a button. The flosser features a simple tension adjustment mechanism, a floss cutter, and floss spool eject button. Includes two 30 yard refill spools.
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
- 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 |
|---|---|---|---|---|---|---|
| Primary | D876222170 | HIBCC |