FDA UDI
In Commercial Distribution
🇺🇸 United States
Rejuvapen
DI: 00860003838112
·
Model: NXT Model 102
·
Refine Usa, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Rejuvapen
- Primary DI
- 00860003838112
- Version / Model
- NXT Model 102
- Company Name
- Refine Usa, LLC
- Labeler DUNS
- 012101731
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-20
- Public Version
- 2
- Public Version Date
- 2023-11-03
- Public Version Status
- Update
- Public Device Record Key
- 02c905ab-9882-4c21-a7e3-1f6ddf0f1cd9
Device Description
Microneedling Skin Rejuvenation. The Rejuvapen product is used to help remove wrinkles in the face area. Microneedling skin rejuvenation or collagen induction therapy.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- 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 |
|---|---|---|---|---|
| 61222 | Cosmetic micro-needling electronic handpiece cartridge, professional | A device intended to be fitted to an electronic cosmetic micro-needling handpiece for the creation of high-density minute skin punctures to stimulate tissue regeneration and improve the appearance of the skin as part of collagen induction therapy (CIT). It is a small, sealed cartridge containing micro-needles intended to be fitted to the distal tip of the handpiece; it does not include any injectable materials. It is intended to be used by a healthcare provider in a clinical setting. It is not intended to be used for energy-based skin treatment. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860003838112 | GS1 |