Identity
- Trade Name
- Rejuvapen FDA UDI
- Generic Name
- Cosmetic micro-needling electronic handpiece cartridge, professional FDA UDI
- Device Name
- Microneedling Skin Rejuvenation. The Rejuvapen product is used to help remove wrinkles in the face area. Microneedling skin rejuvenation or collagen induction therapy. FDA UDI
- Model / Reference
- NXT Model 102 FDA UDI
- Description
- Microneedling Skin Rejuvenation. The Rejuvapen product is used to help remove wrinkles in the face area. Microneedling skin rejuvenation or collagen induction therapy. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860003838112 FDA UDI
- FDA Product Code
- QAI FDA UDI
- GMDN Term
- Cosmetic micro-needling electronic handpiece cartridge, professional FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4430 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cosmetic micro-needling electronic handpiece cartridge, professional
Rejuvapen by Refine USA, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Refine USA, LLC
Sources (1)
- FDA UDI 02c905ab-9882-4c21-a7e3-1f6ddf0f1cd9 33 fields · synced May 30, 2026