FDA UDI
In Commercial Distribution
🇺🇸 United States
ADULT FLOSSER PIKS
DI: D89260705401271
·
Model: 6070540127
·
MAXILL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
5
Basic Information
- Brand Name
- ADULT FLOSSER PIKS
- Primary DI
- D89260705401271
- Version / Model
- 6070540127
- Company Name
- MAXILL, INC.
- Labeler DUNS
- 079343581
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2022-09-06
- Public Version
- 1
- Public Version Date
- 2022-09-14
- Public Version Status
- New
- Public Device Record Key
- 2d88bcb6-a37a-4446-be7e-363d2a3c4d3a
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 | D89260705401272 | HIBCC | Bundle | 120 | In Commercial Distribution | |
| Primary | D89260705401271 | HIBCC | ||||
| Package | D89260705401273 | HIBCC | Case | 6000 | In Commercial Distribution | |
| Unit of Use | D89260705401270 | HIBCC |