FDA UDI
In Commercial Distribution
🇺🇸 United States
Bestview
DI: 06974892092013
·
Model: BW-203B
·
ZHENGZHOU BESTVIEW ST CO., LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Bestview
- Primary DI
- 06974892092013
- Version / Model
- BW-203B
- Company Name
- ZHENGZHOU BESTVIEW ST CO., LTD
- Labeler DUNS
- 421330673
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-01-24
- Public Version
- 1
- Public Version Date
- 2022-02-01
- Public Version Status
- New
- Public Device Record Key
- 5c6aa19e-2353-460e-88fd-8cf67521bd5e
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
- No
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| 64098 | General/multiple surgical carbon dioxide laser system | A mains electricity (AC-powered) device assembly in which input energy is used to excite carbon dioxide (CO2) to emit a high-power laser beam intended to incise, excise, ablate, vaporize and coagulate soft tissues across multiple clinical specialties (e.g., dermatological, gynaecological, ENT) using both ablative and non-ablative lasing; it is not dedicated to a specific specialty. It typically includes a light source, delivery/positioning device(s), and controls/foot-switch. It does not include a therapeutic solid-state or diode laser. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06974892092013 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211735 | 000 |