Bluewave™ Soft Tissue Diode Laser
- Primary DI
- 07540172017107
- Brand
- Bluewave™ Soft Tissue Diode Laser
- Company
- CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
- Model
- 444000
- Catalog number
- 444000
- Device description
- Dental diode laser system
- Published
- 2019-10-20
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Contact Domains
clinicianschoice.comProduct Codes
| Code | Name |
|---|---|
| GEX | Powered laser surgical instrument |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 07540172017107 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 07540172017107 | 07540172017107 | 7540172017107 |
GMDN Terms
| Term | Definition |
|---|---|
| Dental diode laser system | A mains electricity (AC-powered) device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to cut, excise, vaporize, and coagulate oral tissues in various dental applications such as oral soft-tissue surgery, gingivectomy, to diminish inflammation, and for oral therapy and tooth whitening; it is not a dedicated tooth-bleaching acceleration unit. It includes a portable diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch; it may include a rechargeable battery. |
Storage And Handling
| Type | Low | High | Condition |
|---|---|---|---|
| Special Storage Condition, Specify | 0 | 0 | Keep dry. Do not expose to humidy levels exceeding 90%. Do not expose to atmospheric pressure lower than 70kPa, or higher than 106kPa. |
Sterilization Methods
| Method |
|---|
Contacts
| Phone | |
|---|---|
| +1(800)265-3444 | info@clinicianschoice.com |
Regulatory Flags
- DUNS number
- 626406016
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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