| Primary Device ID | 00816611025925 |
| NIH Device Record Key | 08fa6a6b-e067-41f1-bf9b-f894fbab7bc4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Angiosystems inc |
| Version Model Number | sx8200 case |
| 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 | 00816611025925 [Primary] |
| KPY | Shield, Protective, Personnel |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00816611025925]
Ethylene Oxide
[00816611025925]
Ethylene Oxide
[00816611025925]
Ethylene Oxide
[00816611025925]
Ethylene Oxide
[00816611025925]
Ethylene Oxide
[00816611025925]
Ethylene Oxide
[00816611025925]
Ethylene Oxide
[00816611025925]
Ethylene Oxide
[00816611025925]
Ethylene Oxide
[00816611025925]
Ethylene Oxide
[00816611025925]
Ethylene Oxide
[00816611025925]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-03 |
| Device Publish Date | 2024-09-25 |
| 00816611026564 - AngioSystems Tray | 2025-07-03 |
| 00816611026540 - AngioSystems Tray | 2025-05-19 |
| 00816611026526 - AngioSystems Tray | 2025-04-22 |
| 00816611026502 - AngioSystems Drape | 2025-04-10 |
| 10816611026479 - AngioSystems Drape | 2025-02-17 |
| 10816611026486 - AngioSystems Drape | 2025-02-17 |
| 00816611026014 - AngioSystems Tray | 2025-02-10 |
| 00816611026038 - AngioSystems Tray | 2025-02-10 |