| 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 |