| Primary Device ID | 00816703028599 |
| NIH Device Record Key | 2d2d5cf1-9baf-4ac8-8b1a-8bac2e684584 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MedSource Gloves |
| Version Model Number | MS-64112 |
| Catalog Number | Not Applicable |
| Company DUNS | 041674552 |
| Company Name | MEDSOURCE INTERNATIONAL LLC |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816703028582 [Primary] |
| GS1 | 00816703028599 [Package] Contains: 00816703028582 Package: Case [10 Units] In Commercial Distribution |
| PXC | Personal Protection Kit |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-07-30 |
| Device Publish Date | 2021-07-22 |
| 00816703028612 | Vinyl PF Gloves - X Large |
| 00816703028599 | GlovePlus Latex PF Exam Glove- Small |
| 00816703028575 | Nitrile Gloves - Large |
| 00816703028551 | Nitrile Gloves - Medium |
| 00840155403376 | X-Large Black Examination Gloves |
| 00840155403345 | Black Examination Gloves |
| 00816703025734 | Nitrile Gloves PF Large |