FDA UDI
In Commercial Distribution
🇺🇸 United States
SkinPen Precision Elite
DI: 00850060751028
·
Model: REF015
·
Bellus Medical, LLC
Product Codes
1
GMDN Terms
1
Identifiers
8
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- SkinPen Precision Elite
- Primary DI
- 00850060751028
- Version / Model
- REF015
- Catalog Number
- F5SP388
- 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
- 5
- Public Version Date
- 2025-04-24
- Public Version Status
- Update
- Public Device Record Key
- 8fb7ba69-7f0d-4307-be8c-413d82b5665a
Device Description
SPP Elite Microneedling Cartridge
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | 00850060751073 | GS1 | Box | 1 | In Commercial Distribution | |
| Primary | 00850060751028 | GS1 | ||||
| Package | 00850060751066 | GS1 | Case | 24 | In Commercial Distribution | |
| Package | 00850060751080 | GS1 | Mixed Case | 24 | In Commercial Distribution | |
| Package | 00850060751097 | GS1 | Mixed Case | 12 | In Commercial Distribution | |
| Package | 00850060751189 | GS1 | Box | 1 | In Commercial Distribution | |
| Package | 00850060751288 | GS1 | Mixed Case | 12 | In Commercial Distribution | |
| Package | 00850060751301 | GS1 | Mixed Case | 12 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-888-372-3982
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K241400 | 000 |