| Primary Device ID | 06974632230019 |
| NIH Device Record Key | 39e1bc9f-9b24-4a8f-822a-2ee8d8d9abed |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GIGAA |
| Version Model Number | VELAII-15D |
| Company DUNS | 529611032 |
| Company Name | Wuhan Gigaa Optronics Technology 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06970460900001 [Previous] |
| GS1 | 06974632230019 [Primary] |
| GS1 | 06974632230361 [Package] Package: case [1 Units] In Commercial Distribution |
| GEX | Powered Laser Surgical Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-02 |
| Device Publish Date | 2022-10-25 |
| 06970460900070 | VELASⅡ-60C |
| 06970460900063 | VELASⅡ-60B |
| 06970460900056 | VELASⅡ-60A |
| 06970460900049 | VELASⅡ-30B |
| 06970460900032 | VELASⅡ-30A |
| 06970460900025 | GBOX-15B |
| 06970460900018 | GBOX-15A |
| 06970460900001 | VELASⅡ-15D |
| 06974632230019 | VELAII-15D |