| Primary Device ID | 04059497000747 |
| NIH Device Record Key | 33139de2-393e-4a00-aa2f-b78c9543f417 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CoolLipoTM |
| Version Model Number | CL 500 S |
| Catalog Number | M210608S |
| Company DUNS | 342703174 |
| Company Name | LEONI Fiber Optics GmbH |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| 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 | 04059497000723 [Primary] |
| GS1 | 04059497000730 [Package] Contains: 04059497000723 Package: [5 Units] In Commercial Distribution |
| GS1 | 04059497000747 [Package] Contains: 04059497000730 Package: [2 Units] In Commercial Distribution |
| GEX | Powered laser surgical instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-29 |
| 04059497000747 | CL 500 S |
| 04059497000358 | CL 320 R |
| 04059497000587 | CL 500 R |
| 04059497000273 | CL 320 S |