| Primary Device ID | 10878799000870 |
| NIH Device Record Key | 2535a696-ae94-44b4-8b28-0b80ff16b0b7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SURGISTAR |
| Version Model Number | 5522 |
| 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 | 00878799000873 [Primary] |
| GS1 | 10878799000870 [Package] Contains: 00878799000873 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 | 2016-06-08 |