| Primary Device ID | 00817495022383 |
| NIH Device Record Key | 5dafffd3-f4fe-4b42-807e-a3ab76f72c8c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GentleLase 6/8/10MM RGD Delivery System W/O Fiber |
| Version Model Number | 7122-00-8506 |
| Company DUNS | 053468385 |
| Company Name | CANDELA CORPORATION |
| 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 | true |
| 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 | 00817495022383 [Primary] |
| GS1 | 08174950202387 [Previous] |
| GEX | Powered Laser Surgical Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2021-05-24 |
| Device Publish Date | 2016-09-23 |
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