FDA UDI
In Commercial Distribution
🇺🇸 United States
EndyMed Pure iFine Handpiece
DI: 07290016814033
·
Model: iFine Handpiece
·
ENDYMED MEDICAL LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EndyMed Pure iFine Handpiece
- Primary DI
- 07290016814033
- Version / Model
- iFine Handpiece
- Catalog Number
- ND_PRD00075
- Company Name
- ENDYMED MEDICAL LTD
- Labeler DUNS
- 531958689
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-12-31
- Public Version
- 2
- Public Version Date
- 2019-03-21
- Public Version Status
- Update
- Public Device Record Key
- 583f1839-227c-412a-9b73-e9434d26a973
Device Description
The handpiece is used as an accessory to EndyMed Pure system, which is a noninvasive device intended for use in Dermatologic and General Surgical procedures. The handpiece is indicated for mild to moderate facial wrinkles and rhytides.
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44832 | Multi-modality skin contouring system | An assembly of devices that uses a combination of energies to temporarily minimize the manifestation of cellulite and loose or wrinkled skin. It typically consists of an applicator attached to an energy-producing generator and possibly other components. The applicator is applied to the body and may emit radio-frequency [typically in the bands of 1 megahertz (MHz)], infrared light, and/or other forms of energy, to heat skin/subdermal tissues for the production of a smooth-skin appearance. Vacuum may also be included. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290016814033 | GS1 |
Customer Contacts
- Phone
- 1-855-363-9633
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K120513 | 000 |