FDA UDI
In Commercial Distribution
🇺🇸 United States
HYDRA BEAUTY
DI: 08800060501644
·
Model: ESK-2212HB
·
EUNSUNG GLOBAL CORP.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
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Basic Information
- Brand Name
- HYDRA BEAUTY
- Primary DI
- 08800060501644
- Version / Model
- ESK-2212HB
- Company Name
- EUNSUNG GLOBAL CORP.
- Labeler DUNS
- 689372738
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-22
- Public Version
- 1
- Public Version Date
- 2022-09-30
- Public Version Status
- New
- Public Device Record Key
- 1477c36b-53fa-4dbc-bd2b-b1d9cac35248
Device Description
Hydra Beauty is equipped with two functions. First, the ‘Aqua peel cleansing’ which is using chemical peel to help clear skin pores and eliminating hazardous wastes. Secondly, Low frequency radiofrequency (EP) stimulates muscle relaxation and hormone secretion for pain relief.
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
- 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 |
|---|---|---|---|---|
| GFE | Brush, Dermabrasion, Powered | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35372 | Analgesic transcutaneous electrical nerve stimulation system | An assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800060501644 | GS1 | ||||
| Package | 18800060501641 | GS1 | PALLET | 1 | In Commercial Distribution | |
| Package | 28800060501648 | GS1 | PALLET | 2 | In Commercial Distribution | |
| Package | 38800060501645 | GS1 | PALLET | 4 | In Commercial Distribution |