FDA UDI
In Commercial Distribution
🇺🇸 United States
Elite
DI: 00850057194111
·
Model: 2022-EL
·
Clareblend, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Elite
- Primary DI
- 00850057194111
- Version / Model
- 2022-EL
- Company Name
- Clareblend, Inc.
- Labeler DUNS
- 139701114
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-14
- Public Version
- 1
- Public Version Date
- 2023-12-22
- Public Version Status
- New
- Public Device Record Key
- 96f8b5c2-57c6-4ddf-8059-afe21030f6d0
Device Description
Electrology Hair Removal (Needle Epilation)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| KCW | EPILATOR, HIGH FREQUENCY, NEEDLE-TYPE | General, Plastic Surgery | 878.5350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43642 | Professional hair-removal electrolysis system | An assembly of devices intended to permanently remove unwanted body hair by destroying the dermal papilla (hair root) through application of an electric current at the tip of a fine needle electrode that is inserted close to the hair shaft, under the skin, and into the dermal papilla. It typically includes an electrically-powered control unit, a handpiece that connects to the control unit and holds the disposable electrode, and a foot-switch. The system is typically available in three types: galvanic (applies DC), thermolysis/high-frequency (applies AC), and blend (applies DC/AC combination). It is intended to be operated by a trained professional and may be referred to as an epilator. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850057194111 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry