| Primary Device ID | 14953170441278 |
| NIH Device Record Key | 5bdee026-6644-4995-b789-fd9492bfb7f1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SINGLE USE DISTAL COVER MAJ-2315 |
| Version Model Number | MAJ-2315 |
| Catalog Number | N6192000 |
| Company DUNS | 711789789 |
| Company Name | OLYMPUS MEDICAL SYSTEMS CORP. |
| 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 | true |
| Manufacturing Date | true |
| 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 | 04953170441271 [Primary] |
| GS1 | 14953170441278 [Package] Contains: 04953170441271 Package: [20 Units] In Commercial Distribution |
| GS1 | 54953170441276 [Package] Package: [60 Units] In Commercial Distribution |
| FDT | Duodenoscope And Accessories, Flexible/Rigid |
| FEB | Accessories, Cleaning, For Endoscope |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-06-09 |
| Device Publish Date | 2022-06-01 |