FDA UDI
In Commercial Distribution
🇺🇸 United States
Bluewave™ Soft Tissue Diode Laser
DI: 00359883006587
·
Model: 444000
·
DEN-MAT HOLDINGS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Bluewave™ Soft Tissue Diode Laser
- Primary DI
- 00359883006587
- Version / Model
- 444000
- Catalog Number
- 444000
- Company Name
- DEN-MAT HOLDINGS, LLC
- Labeler DUNS
- 809857704
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-12
- Public Version
- 1
- Public Version Date
- 2025-03-20
- Public Version Status
- New
- Public Device Record Key
- 91e27153-0075-478b-9ed1-f1874573c13c
Device Description
Dental diode laser system
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| GEX | Powered laser surgical instrument | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60340 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00359883006587 | GS1 |
Customer Contacts
- Phone
- +1(800)433-6628
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141838 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry. Do not expose to humidy levels exceeding 90%. Do not expose to atmospheric pressure lower than 70kPa, or higher than 106kPa.
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius