| Primary Device ID | 10878799001822 | 
| NIH Device Record Key | bcd502a8-d370-42a0-8132-ac00d417cfa8 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | SURGISTAR | 
| Version Model Number | 6825 | 
| Company DUNS | 808865125 | 
| Company Name | SURGISTAR, INC. | 
| 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 | 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 | 00878799001825 [Primary] | 
| GS1 | 10878799001822 [Package] Contains: 00878799001825 Package: [6 Units] In Commercial Distribution | 
| GDX | Scalpel, One-Piece | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 3 | 
| Public Version Date | 2018-07-06 | 
| Device Publish Date | 2016-07-07 |