FDA UDI
In Commercial Distribution
🇺🇸 United States
SkinPen Precision Treatment Kits
DI: 10863221000320
·
Model: 1
·
Bellus Medical, LLC
Product Codes
1
GMDN Terms
3
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SkinPen Precision Treatment Kits
- Primary DI
- 10863221000320
- Version / Model
- 1
- Catalog Number
- F5SP018
- Company Name
- Bellus Medical, LLC
- Labeler DUNS
- 005677967
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-09
- Public Version
- 9
- Public Version Date
- 2023-11-03
- Public Version Status
- Update
- Public Device Record Key
- 1efd35fc-3468-4ccf-b326-678dd2347089
Device Description
Case of 12 SkinPen Precision Treatment Plus Kits
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
- Yes
- Sterilization Methods
- Ethylene Oxide
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 |
| 47764 | Wound hydrogel dressing, non-antimicrobial | A wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). This is a single-use device. | No | Active |
| 12535 | Medical equipment drape, single-use | A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10863221000320 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN160029 | 000 |