| Primary Device ID | 00850032938136 |
| NIH Device Record Key | feabc5dc-5dbc-4450-a983-e243db278bb6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Prism Health |
| Version Model Number | PN1001 |
| Company DUNS | 118806738 |
| Company Name | Nautilus Gloves LLC |
| 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 | true |
| 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 | 00850032938136 [Primary] |
| LZA | Polymer Patient Examination Glove |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-12 |
| Device Publish Date | 2022-12-02 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PRISM HEALTH 87250995 5298194 Live/Registered |
Cascade AIDS Project 2016-11-29 |