FDA UDI
In Commercial Distribution
🇺🇸 United States
PURE DentA
DI: 07290016814668
·
Model: PURE DentA 110V
·
ENDYMED MEDICAL LTD
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PURE DentA
- Primary DI
- 07290016814668
- Version / Model
- PURE DentA 110V
- Catalog Number
- ND_PRD00480-00
- Company Name
- ENDYMED MEDICAL LTD
- Labeler DUNS
- 531958689
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-06
- Public Version
- 2
- Public Version Date
- 2025-06-30
- Public Version Status
- Update
- Public Device Record Key
- b20eabaf-f2d0-4391-b210-703139f7201e
Device Description
The ENDYMED PURE DentA is a device intended for use in Dermatologic and General Surgical Procedures.
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
- 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 |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
| OUH | Skin Resurfacing Rf Applicator | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44832 | Multi-modality skin/body contouring system | An assembly of devices intended to use a combination of noninvasive energies and methods to locally reduce the subcutaneous fat layer, cellulite manifestation, and loose or wrinkled skin appearance. It consists of an electrically-powered control unit/generator to produce two or more energy modalities [e.g., radio-frequency, thermal/cryogenic (for cryolipolysis), high intensity focused ultrasound (HIFU), infrared light], and body-surface applicators to apply the treatment to the target area (e.g., chin, hips, abdomen, thighs); some types are additionally capable of applying vacuum. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290016814668 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K120513 | 000 |