FDA UDI
In Commercial Distribution
🇺🇸 United States
Nuaskin Skin Tag Remover
DI: 00860003125588
·
Model: FY-111
·
HOME AIDE DIAGNOSTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Nuaskin Skin Tag Remover
- Primary DI
- 00860003125588
- Version / Model
- FY-111
- Company Name
- HOME AIDE DIAGNOSTICS, INC.
- Labeler DUNS
- 783518983
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-11-25
- Public Version
- 1
- Public Version Date
- 2020-12-03
- Public Version Status
- New
- Public Device Record Key
- de7e31a0-f6d0-4c78-bfaf-d9f5a0a4e984
Device Description
For use on: Skin Vegetations Fatty Grains Freckles Age Spots Warts Verruca Large Moles Large Freckles
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| MIJ | Needle, Tumor Localization | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13472 | Scarifier | A hand-held manual surgical instrument consisting of many sharp points or cutting blades intended to be used to produce many small, superficial scratches or punctures in the skin, as for the introduction of smallpox vaccine. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10860003125585 | GS1 | Outer Carton | 50 | In Commercial Distribution | |
| Primary | 00860003125588 | GS1 |
Customer Contacts
- Phone
- 1-800-915-0116
- [email protected]