| Primary Device ID | 08800035500313 |
| NIH Device Record Key | 682b5502-8041-4239-b036-32be74b3c24d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PALLAS body |
| Version Model Number | PALLAS body |
| Company DUNS | 689856875 |
| Company Name | Laseroptek Co.,Ltd |
| 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 |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800035500245 [Primary] |
| GS1 | 08800035500313 [Package] Contains: 08800035500245 Package: Carton box [1 Units] In Commercial Distribution |
| GS1 | 08800035500757 [Package] Contains: 08800035500245 Package: Wooden box [1 Units] Discontinued: 2019-11-21 Not in Commercial Distribution |
| 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 | 2019-11-21 |
| Device Publish Date | 2018-01-15 |
| 08800035500313 | PALLAS body |
| 00088000355931 | PALLAS body |