| Primary Device ID | 04961333240128 |
| NIH Device Record Key | 2a43ed9a-b36e-4305-92d4-fc3428e3cc31 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VIDEO DUODENOSCOPE |
| Version Model Number | ED34-I10T |
| Company DUNS | 083211284 |
| Company Name | PENTAX OF AMERICA, 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04961333240128 [Primary] |
| FDT | Duodenoscope And Accessories, Flexible/Rigid |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04961333240128]
Ethylene Oxide;High-level Disinfectant
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-01-23 |
| Device Publish Date | 2018-03-10 |
| 04961333240142 | C.A.P. HD DUODENOSCOPE (US USED) |
| 04961333240135 | VIDEO DUODENOSCOPE (USED) |
| 04961333240128 | VIDEO DUODENOSCOPE - I10 STANDARD (INTERNATIONAL USED) |
| 04961333232956 | C.A.P. HD DUODENOSCOPE (US NEW) |
| 04961333232420 | ED-3490TK VIDEO DUODENOSCOPE (REFURBISHED) |