| Primary Device ID | 00816611022344 |
| NIH Device Record Key | 57700cc3-4d73-4146-a65e-edf9f6ef51d7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AngioSystems SorbX |
| Version Model Number | SX8100 |
| Company DUNS | 144884467 |
| Company Name | ANGIOSYSTEMS, INCORPORATED |
| 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 | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 | 00816611022337 [Primary] |
| GS1 | 00816611022344 [Package] Contains: 00816611022337 Package: [15 Units] In Commercial Distribution |
| GS1 | 00816611025994 [Package] Package: CASE [30 Units] In Commercial Distribution |
| KPY | Shield, Protective, Personnel |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2018-02-05 |