FDA UDI
In Commercial Distribution
🇺🇸 United States
SkinPen Precision Elite
DI: 00850060751011
·
Model: REF201
·
Bellus Medical, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- SkinPen Precision Elite
- Primary DI
- 00850060751011
- Version / Model
- REF201
- Catalog Number
- F5SP387, F5SP419, F5SP454
- Company Name
- Bellus Medical, LLC
- Labeler DUNS
- 005677967
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-01
- Public Version
- 3
- Public Version Date
- 2025-01-06
- Public Version Status
- Update
- Public Device Record Key
- 669ca65d-db1e-45d6-9cb0-bb21e705534c
Device Description
SPP Elite Charging Base
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
- No
- 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 |
|---|---|---|---|---|
| QAI | Powered Microneedle Device | General, Plastic Surgery | 878.4430 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61216 | Cosmetic micro-needling electronic handpiece, professional | A hand-held, electrically-powered device intended to be used in combination with a micro-needle cartridge (which contains micro-needles) to create high-density minute skin punctures to stimulate tissue regeneration and improve the appearance of the skin as part of collagen induction therapy (CIT). It includes controls to allow for treatment adjustments (e.g., puncture depth, frequency); a disposable micro-needle cartridge may be included. It is intended for clinical use by a healthcare provider to treat stretch marks, acne scarring, hyperpigmentation, wrinkles, and/or hair loss; it is not intended for energy-based skin treatment. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850060751011 | GS1 | ||||
| Package | 00850060751059 | GS1 | Box | 1 | In Commercial Distribution | |
| Package | 00850035498910 | GS1 | Box | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-888-372-3982
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K241400 | 000 |