FDA UDI
In Commercial Distribution
🇺🇸 United States
ZIIP Beauty
DI: 00851367006200
·
Model: HALO - CN
·
ZIIP, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ZIIP Beauty
- Primary DI
- 00851367006200
- Version / Model
- HALO - CN
- Company Name
- ZIIP, INC.
- Labeler DUNS
- 079593493
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-07
- Public Version
- 1
- Public Version Date
- 2025-08-15
- Public Version Status
- New
- Public Device Record Key
- e217151c-cef8-482a-b9e5-978167c6651b
Device Description
ZIIP HALO - CN
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| NFO | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | Neurology | 882.5890 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66566 | Facial muscle cosmesis electrical stimulator | An electrically-powered, hand-held device intended to be used in the home to apply electrical stimuli to the facial muscles through the skin (transcutaneously), to improve muscle tone and help tighten overlying skin for cosmetic facial rejuvenation. It includes electrodes at the distal end and controls to adjust the electrical impulse intensity; it is typically used with a gel, which may be supplied with the device, intended to facilitate conduction of the electrical current. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851367006200 | GS1 |
Customer Contacts
- Phone
- 18009447031
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212342 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 95 Percent (%) Relative Humidity