FDA UDI
In Commercial Distribution
🇺🇸 United States
SKINEXIANS
DI: 03760394190004
·
Model: FULLSKIN V7
·
SKINEXIANS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SKINEXIANS
- Primary DI
- 03760394190004
- Version / Model
- FULLSKIN V7
- Catalog Number
- 65.011
- Company Name
- SKINEXIANS
- Labeler DUNS
- 276134694
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-19
- Public Version
- 2
- Public Version Date
- 2025-06-30
- Public Version Status
- Update
- Public Device Record Key
- 81fc4125-df6a-48f5-b77a-620348ad42d1
Device Description
110V therapeutic massager device for aesthetic purposes including all the accessories for its marketing and use.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| ISA | Massager, Therapeutic, Electric | Physical Medicine | 890.5660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 67223 | Vacuum suction skin/body contouring system | An electrically-powered assembly of noninvasive devices intended primarily for the temporarily reduction in the appearance of cellulite through the application of suction forces to the skin surface. It includes a motorized vacuum pump, a control unit, and one or more hand-held skin-surface applicators (cups). The system may in addition be used to improve skin appearance by smoothing wrinkles, tightening muscle/connective tissue, and/or improving lymphatic drainage; it may also be used as a massager to treat minor muscle pain. It is intended to be operated by a trained professional. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03760394190004 | GS1 |
Customer Contacts
- Phone
- 6789088180
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Pressure | 880 | millibar |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius