| Primary Device ID | 04953170436758 |
| NIH Device Record Key | c8b13ba8-8b11-4ce5-bfbc-05e2549b221c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE |
| Version Model Number | OLYMPUS GIF-H190 |
| Catalog Number | N3803041 |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04953170436758 [Primary] |
| FDF | Colonoscope And Accessories, Flexible/Rigid |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04953170436758]
High-level Disinfectant;Ethylene Oxide
[04953170436758]
High-level Disinfectant;Ethylene Oxide
[04953170436758]
High-level Disinfectant;Ethylene Oxide
[04953170436758]
High-level Disinfectant;Ethylene Oxide
[04953170436758]
High-level Disinfectant;Ethylene Oxide
[04953170436758]
High-level Disinfectant;Ethylene Oxide
[04953170436758]
High-level Disinfectant;Ethylene Oxide
[04953170436758]
High-level Disinfectant;Ethylene Oxide
[04953170436758]
High-level Disinfectant;Ethylene Oxide
[04953170436758]
High-level Disinfectant;Ethylene Oxide
[04953170436758]
High-level Disinfectant;Ethylene Oxide
[04953170436758]
High-level Disinfectant;Ethylene Oxide
[04953170436758]
High-level Disinfectant;Ethylene Oxide
[04953170436758]
High-level Disinfectant;Ethylene Oxide
[04953170436758]
High-level Disinfectant;Ethylene Oxide
[04953170436758]
High-level Disinfectant;Ethylene Oxide
[04953170436758]
High-level Disinfectant;Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-05-01 |
| Device Publish Date | 2023-04-22 |
| 04953170343360 | GIF-1TH190 GIF-1TH190 EVIS EXERA III HIG |
| 04953170305290 | GIF-H190 EVIS EXERA III HDTV GASTROSCOPE |
| 04953170305276 | GIF-HQ190 EVIS EXERA III HDTV DF NBI |
| 04953170437014 | OLYMPUS GIF-1TH190 |
| 04953170436758 | OLYMPUS GIF-H190 |
| 04953170436734 | OLYMPUS GIF-HQ190 |
| 04953170452475 | OLYMPUS GIF-1TH190 |