| Primary Device ID | 00810014630281 |
| NIH Device Record Key | 71463d1d-b328-4b26-a8e0-d6a71e9e30ad |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SurgyNeedle |
| Version Model Number | 780-417 |
| Company DUNS | 142007082 |
| Company Name | U.S. SURGITECH INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| 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 | 00810014630274 [Primary] |
| GS1 | 00810014630281 [Package] Contains: 00810014630274 Package: Box [10 Units] In Commercial Distribution |
| GS1 | 00810014630298 [Package] Package: Box [100 Units] In Commercial Distribution |
| GAA | Needle, Aspiration And Injection, Disposable |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-05-18 |
| Device Publish Date | 2020-05-10 |
| 00810014635132 | 5mm disposable aspiration needle, 21ga needle, 40cm length |
| 00810014635101 | 5mm disposable aspiration needle, 15ga needle, 40cm length |
| 00810014630281 | 780-417 |
| 00810014630250 | 780-416 |
| 00810014630120 | 780-415 |
| 10810014630073 | 780-414 |
| 10810014630066 | 780-413 |