FDA UDI
In Commercial Distribution
🇺🇸 United States
Legend Pro Hybrid Energy (HE) disposable tips
DI: 07290016586213
·
Model: gen100
·
POLLOGEN LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- Legend Pro Hybrid Energy (HE) disposable tips
- Primary DI
- 07290016586213
- Version / Model
- gen100
- Catalog Number
- 30010150LP
- Company Name
- POLLOGEN LTD
- Labeler DUNS
- 514905681
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2019-05-12
- Public Version
- 1
- Public Version Date
- 2019-05-20
- Public Version Status
- New
- Public Device Record Key
- 30128726-2aab-4ad4-a863-d521a4923c13
Device Description
Legend Pro Hybrid Energy (HE) disposable tips gen100
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|
| 45048 | Radio-frequency skin contouring system applicator tip | A removable endpiece that is attached to a radio-frequency (RF) skin contouring system applicator (handpiece), used to regulate the delivery of RF energy to the patient during treatment. As a procedural safety measure, the device may permit the transfer of energy only when a correct surface contact is established. It may also be used to cool the skin and monitor its temperature to protect the epidermis during treatment. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290016586213 | GS1 | ||||
| Unit of Use | 17290016586210 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K173503 | 000 |