FDA UDI
In Commercial Distribution
🇺🇸 United States
EndyMed Pro FSR Handpiece
DI: 07290016814125
·
Model: Pro FSR Handpiece
·
ENDYMED MEDICAL LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EndyMed Pro FSR Handpiece
- Primary DI
- 07290016814125
- Version / Model
- Pro FSR Handpiece
- Catalog Number
- ND_PRD00013
- 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
- 4
- Public Version Date
- 2023-11-21
- Public Version Status
- Update
- Public Device Record Key
- a9056635-353c-4cb7-a7aa-a481c6a860b7
Device Description
The handpiece is used as an accessory to EndyMed Pro system, which is a noninvasive device intended for use in Dermatologic and General Surgical procedures. The handpiece is indicated for Dermatological procedures requiring ablation and resurfacing of the skin.
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 |
|---|---|---|---|---|
| OUH | Skin Resurfacing Rf Applicator | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58455 | Radio-frequency skin surface treatment system applicator | A handpiece component of a radio-frequency skin surface treatment system designed to be used by a healthcare professional to deliver bipolar radio-frequency (RF) energy to the skin surface for skin resurfacing. It is typically designed to deliver RF energy to the skin in a non-homogenous fractional manner, via an array of multi-electrode pins, to leave minimal-impact areas of skin to facilitate healing. The applicator connects with the system’s control unit and may include vacuum to facilitate its coupling with the skin. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290016814125 | GS1 |
Customer Contacts
- Phone
- 1-855-363-9633
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K101510 | 000 |