| Primary Device ID | 10878799002638 |
| NIH Device Record Key | 14539521-bb34-4e5d-8e20-4f44f4e34bfd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SURGISTAR, INC. |
| Version Model Number | 961669 |
| Catalog Number | LP7595 |
| Company DUNS | 808865125 |
| Company Name | SURGISTAR, INC. |
| 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 |
| Phone | 7605982480 |
| customerservice@surgistar.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00878799002631 [Primary] |
| GS1 | 10878799002638 [Package] Contains: 00878799002631 Package: [6 Units] In Commercial Distribution |
| GS1 | 80878799002637 [Package] Package: [50 Units] In Commercial Distribution |
| GS1 | 90878799002634 [Package] Package: [35 Units] In Commercial Distribution |
| EMF | Knife, Surgical |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-02-06 |
| Device Publish Date | 2017-07-14 |