FDA UDI
In Commercial Distribution
🇺🇸 United States
Freshmint
DI: 00085317008642
·
Model: FLSPK
·
NEW WORLD IMPORTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1000
Basic Information
- Brand Name
- Freshmint
- Primary DI
- 00085317008642
- Version / Model
- FLSPK
- Company Name
- NEW WORLD IMPORTS, INC.
- Labeler DUNS
- 075372276
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1000
- Record Status
- Published
- Publish Date
- 2020-08-13
- Public Version
- 1
- Public Version Date
- 2020-08-21
- Public Version Status
- New
- Public Device Record Key
- 3efb7420-97aa-471f-9b96-fb552494b2d0
Device Description
Freshmint Floss Pick
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 | 00085317008635 | GS1 | Case | 4 | In Commercial Distribution | |
| Primary | 00085317008642 | GS1 | ||||
| Unit of Use | 00085317008680 | GS1 |
Customer Contacts
- Phone
- 800-329-1903
- [email protected]