FDA UDI
In Commercial Distribution
🇺🇸 United States
Waterlase Laser Tips
DI: 00647529002964
·
Model: 7000403
·
Biolase, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Waterlase Laser Tips
- Primary DI
- 00647529002964
- Version / Model
- 7000403
- Catalog Number
- 7000403
- Company Name
- Biolase, Inc.
- Labeler DUNS
- 152165700
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 5
- Public Version Date
- 2023-06-12
- Public Version Status
- Update
- Public Device Record Key
- 12389341-6d9c-4e7f-a3a0-139957c31391
Device Description
A Z3 tip kit containing 5 single-use tips intended for use with Waterlase laser delivery systems. The tips have the same core diameter of 320 microns and vary in length.
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
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 |
|---|---|---|---|---|
| 47880 | Dental solid-state laser system | A mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam intended for application in dental procedures; it does not include frequency-doubling technology. It typically includes a light source, delivery/positioning device(s), controls/foot-switch. It is intended to incise, excise, vaporize, ablate, and coagulate oral soft tissue; and cut, shave, contour, and resect oral bone/teeth. Its high-water affinity and high-fluency pulses produce an exceptionally narrow zone of damage around the soft-tissue vaporization crater. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00647529002964 | GS1 |
Customer Contacts
- Phone
- 1-800-321-6717
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K031140 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 14 | Millimeter | |
| Outer Diameter | 320 | Micrometer | |
| Length | 18 | Millimeter | |
| Length | 22 | Millimeter | |
| Length | 9 | Millimeter |