FDA UDI
In Commercial Distribution
🇺🇸 United States
LuxPen Microneedling Cartridges
DI: 00860015460646
·
Model: MP1209SP
·
T AESTHETICS LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LuxPen Microneedling Cartridges
- Primary DI
- 00860015460646
- Version / Model
- MP1209SP
- Company Name
- T AESTHETICS LLC
- Labeler DUNS
- 104436248
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-20
- Public Version
- 1
- Public Version Date
- 2026-03-30
- Public Version Status
- New
- Public Device Record Key
- 011d31a7-7b96-4cc2-9a39-277a4027ddd9
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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QAI | Powered Microneedle Device | General, Plastic Surgery | 878.4430 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63585 | Water jet flosser | An electrically-powered device intended to provide a high-pressure water jet for dental flossing (removal of plaque and/or debris from between teeth) using a dedicated handpiece. It is normally available [non-prescription] over-the-counter (OTC) fo use in the home or healthcare facility. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860015460646 | GS1 |