| Primary Device ID | 10878799003246 |
| NIH Device Record Key | 68c69c42-aa99-42c6-9431-c9cb0f32c56c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SURGISTAR |
| Version Model Number | 990-102 |
| 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 | 00878799003249 [Primary] |
| GS1 | 10878799003246 [Package] Contains: 00878799003249 Package: [6 Units] In Commercial Distribution |
| GDX | Scalpel, One-Piece |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-11 |
| Device Publish Date | 2019-02-06 |