| Primary Device ID | 00817495022918 |
| NIH Device Record Key | 92df33b7-cb7c-4930-8a71-4043a78f974b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sublime applicator |
| Version Model Number | FG70551 |
| Catalog Number | FG70551 |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817495022918 [Primary] |
| GS1 | 07290109950693 [Previous] |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-30 |
| Device Publish Date | 2023-10-20 |
| 00817495024202 | Sublime Applicator, elos Plus |
| 00817495022918 | Sublime Applicator, eTwo |