| Primary Device ID | 00647529002278 |
| NIH Device Record Key | 9a8c1edd-0302-4515-b407-5b22c9172281 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Waterlase Laser System Gold Handpiece |
| Version Model Number | 6200500 |
| Catalog Number | 6200500 |
| Company DUNS | 152165700 |
| Company Name | BIOLASE, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00647529002278 [Primary] |
| GEX | Powered Laser Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00647529002278]
Moist Heat or Steam Sterilization
[00647529002278]
Moist Heat or Steam Sterilization
[00647529002278]
Moist Heat or Steam Sterilization
[00647529002278]
Moist Heat or Steam Sterilization
[00647529002278]
Moist Heat or Steam Sterilization
[00647529002278]
Moist Heat or Steam Sterilization
[00647529002278]
Moist Heat or Steam Sterilization
[00647529002278]
Moist Heat or Steam Sterilization
[00647529002278]
Moist Heat or Steam Sterilization
[00647529002278]
Moist Heat or Steam Sterilization
[00647529002278]
Moist Heat or Steam Sterilization
[00647529002278]
Moist Heat or Steam Sterilization
[00647529002278]
Moist Heat or Steam Sterilization
[00647529002278]
Moist Heat or Steam Sterilization
[00647529002278]
Moist Heat or Steam Sterilization
[00647529002278]
Moist Heat or Steam Sterilization
[00647529002278]
Moist Heat or Steam Sterilization
[00647529002278]
Moist Heat or Steam Sterilization
[00647529002278]
Moist Heat or Steam Sterilization
[00647529002278]
Moist Heat or Steam Sterilization
[00647529002278]
Moist Heat or Steam Sterilization
[00647529002278]
Moist Heat or Steam Sterilization
[00647529002278]
Moist Heat or Steam Sterilization
[00647529002278]
Moist Heat or Steam Sterilization
[00647529002278]
Moist Heat or Steam Sterilization
[00647529002278]
Moist Heat or Steam Sterilization
[00647529002278]
Moist Heat or Steam Sterilization
[00647529002278]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-09-26 |
| Device Publish Date | 2016-09-15 |
| 00647529002483 | A reusable handpiece intended for use with Waterlase laser systems in a variety of dental hard-t |
| 00647529002278 | A reusable contra-angled handpiece intended for use with Waterlase laser systems in a variety of |