FDA UDI
In Commercial Distribution
🇺🇸 United States
NEWA Kit
DI: 07290014660830
·
Model: 1.5, pink
·
ENDYMED MEDICAL LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NEWA Kit
- Primary DI
- 07290014660830
- Version / Model
- 1.5, pink
- Catalog Number
- ND_PRD00426-00
- Company Name
- ENDYMED MEDICAL LTD
- Labeler DUNS
- 531958689
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-30
- Public Version
- 3
- Public Version Date
- 2023-11-21
- Public Version Status
- Update
- Public Device Record Key
- 07d74d30-d2d8-4a60-ab0b-9e025acb355e
Device Description
The EndyMed Newa is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles for adults woman who have Fitzpatrick skin types I-IV
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- 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
- 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 |
|---|---|---|---|---|
| PAY | Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction | General, Plastic Surgery | 878.4420 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66988 | Home-use radio-frequency skin contouring unit | A device intended to be used by a layperson in the home to apply radio-frequency energy heat to subdermal tissues for reduction of facial wrinkles and cosmetic rejuvenation. It consists of an electrically-powered portable unit designed to be hand-held against the face in circular motions whereby the transcutaneously applied heat induces collagen fibre regeneration and improves skin tightening. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 17290014660837 | GS1 | carton | 10 | Not in Commercial Distribution | 2018-09-30 |
| Primary | 07290014660830 | GS1 |
Customer Contacts
- Phone
- 1-855-363-9633
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN150005 | 000 |