FDA UDI
In Commercial Distribution
🇺🇸 United States
Powered Laser Surgical Instrument-Trixel CO2 Laser
DI: 06970285179026
·
Model: CFL-10
·
Beijing Syntech Laser Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Powered Laser Surgical Instrument-Trixel CO2 Laser
- Primary DI
- 06970285179026
- Version / Model
- CFL-10
- Company Name
- Beijing Syntech Laser Co., Ltd.
- Labeler DUNS
- 528741132
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-29
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 5524dd6e-868f-4224-97da-352311af3e71
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17774 | General/multiple surgical solid-state/carbon dioxide laser system | A mains electricity (AC-powered) device assembly designed to produce two distinct high-power laser beams, one solid-state [e.g., neodymium-doped yttrium-aluminium-garnet (Nd:YAG)] mediated and the other carbon dixoide (CO2) mediated, intended for bloodless incisions during general surgery and/or multiple specialized surgical applications (non-dedicated). It is intended to provide both the cutting capabilities of gas mediated lasing, and the haemostatic abilities of solid-state mediated lasing. It includes a light source, delivery/positioning device(s), and controls/foot-switch. It does not include frequency doubling technology. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06970285179026 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K110434 | 000 |