FDA UDI
In Commercial Distribution
🇺🇸 United States
SP MicroPen EVO Microneedling Cartridge
DI: 00850035498279
·
Model: F5SP223
·
Bellus Medical, LLC
Product Codes
1
GMDN Terms
1
Identifiers
11
Pkg Device Count
1
Basic Information
- Brand Name
- SP MicroPen EVO Microneedling Cartridge
- Primary DI
- 00850035498279
- Version / Model
- F5SP223
- Company Name
- Bellus Medical, LLC
- Labeler DUNS
- 005677967
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-25
- Public Version
- 8
- Public Version Date
- 2023-11-14
- Public Version Status
- Update
- Public Device Record Key
- 4fb72c7a-678a-4198-a500-185a38ffc9f5
Device Description
MicroPen EVO Turbo Safety Cartridge (each). Cartridges are sterilized and packaged individually for single patient use.
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 | 10850035498290 | GS1 | Case | 12 | In Commercial Distribution | |
| Primary | 00850035498279 | GS1 | ||||
| Package | 00850035498330 | GS1 | Case | 2 | In Commercial Distribution | |
| Package | 00850035498293 | GS1 | 1 | In Commercial Distribution | ||
| Package | 00850035498835 | GS1 | Mixed Case | 2 | In Commercial Distribution | |
| Package | 00850035498804 | GS1 | Mixed Case | 2 | In Commercial Distribution | |
| Package | 00850035498323 | GS1 | Mixed Case | 1 | In Commercial Distribution | |
| Package | 00850035498842 | GS1 | Mixed Case | 1 | In Commercial Distribution | |
| Package | 00850035498859 | GS1 | Mixed Case | 1 | In Commercial Distribution | |
| Package | 00850035498880 | GS1 | Each | 1 | In Commercial Distribution | |
| Package | 00850035498897 | GS1 | Mixed Case | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- 888.372.3982
- [email protected]