FDA UDI
In Commercial Distribution
🇺🇸 United States
Tixel Periorbital Handpiece
DI: 07290117524022
·
Model: TPH00001
·
NOVOXEL LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Tixel Periorbital Handpiece
- Primary DI
- 07290117524022
- Version / Model
- TPH00001
- Catalog Number
- TPH00001
- Company Name
- NOVOXEL LTD
- Labeler DUNS
- 600275858
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-10-24
- Public Version
- 1
- Public Version Date
- 2021-11-01
- Public Version Status
- New
- Public Device Record Key
- 8205db56-9001-43d7-bf32-5b97059821be
Device Description
Handpiece used with Tixel System TXLD0002
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
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62363 | Thermo-mechanical skin surface treatment system handpiece | A mains electricity (AC-powered), hand-held device intended to apply repetitive pulsed heat and mechanical force, via an attached heat-conductive handpiece tip, to the skin surface for ablative and/or non-ablative treatment of various skin conditions (e.g., pigmentation, scarring, actinic keratosis, acne, wrinkles) during skin resurfacing and rejuvenation procedures. It is an electronic device with an activation switch designed to connect to the system’s control unit; a handpiece tip may be included. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290117524022 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K202988 | 000 |