| Primary Device ID | 04953170202315 | 
| NIH Device Record Key | 4d334b53-b72c-4fa7-9f3d-58cecc264c0e | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | EVIS EXERA II COLONOVIDEOSCOPE | 
| Version Model Number | OLYMPUS CF TYPE Q180AL | 
| Company DUNS | 711789789 | 
| Company Name | OLYMPUS MEDICAL SYSTEMS CORP. | 
| Device Count | 1 | 
| DM Exempt | true | 
| 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 | true | 
| 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 | |
| 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 | |
| Phone | +1(800)401-1086 | 
| xx@xx.xx | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 04953170202315 [Primary] | 
| NWB | Endoscope, accessories, narrow band spectrum | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[04953170202315]
High-level Disinfectant;Ethylene Oxide
[04953170202315]
High-level Disinfectant;Ethylene Oxide
[04953170202315]
High-level Disinfectant;Ethylene Oxide
[04953170202315]
High-level Disinfectant;Ethylene Oxide
[04953170202315]
High-level Disinfectant;Ethylene Oxide
[04953170202315]
High-level Disinfectant;Ethylene Oxide
[04953170202315]
High-level Disinfectant;Ethylene Oxide
[04953170202315]
High-level Disinfectant;Ethylene Oxide
[04953170202315]
High-level Disinfectant;Ethylene Oxide
[04953170202315]
High-level Disinfectant;Ethylene Oxide
[04953170202315]
High-level Disinfectant;Ethylene Oxide
[04953170202315]
High-level Disinfectant;Ethylene Oxide
[04953170202315]
High-level Disinfectant;Ethylene Oxide
[04953170202315]
High-level Disinfectant;Ethylene Oxide
[04953170202315]
High-level Disinfectant;Ethylene Oxide
[04953170202315]
High-level Disinfectant;Ethylene Oxide
[04953170202315]
High-level Disinfectant;Ethylene Oxide
[04953170202315]
High-level Disinfectant;Ethylene Oxide
[04953170202315]
High-level Disinfectant;Ethylene Oxide
[04953170202315]
High-level Disinfectant;Ethylene Oxide
[04953170202315]
High-level Disinfectant;Ethylene Oxide
[04953170202315]
High-level Disinfectant;Ethylene Oxide
[04953170202315]
High-level Disinfectant;Ethylene Oxide
[04953170202315]
High-level Disinfectant;Ethylene Oxide
[04953170202315]
High-level Disinfectant;Ethylene Oxide
[04953170202315]
High-level Disinfectant;Ethylene Oxide
[04953170202315]
High-level Disinfectant;Ethylene Oxide
[04953170202315]
High-level Disinfectant;Ethylene Oxide
[04953170202315]
High-level Disinfectant;Ethylene Oxide
[04953170202315]
High-level Disinfectant;Ethylene Oxide
[04953170202315]
High-level Disinfectant;Ethylene Oxide
[04953170202315]
High-level Disinfectant;Ethylene Oxide
[04953170202315]
High-level Disinfectant;Ethylene Oxide
[04953170202315]
High-level Disinfectant;Ethylene Oxide
[04953170202315]
High-level Disinfectant;Ethylene Oxide
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 4 | 
| Public Version Date | 2018-10-08 | 
| Device Publish Date | 2016-09-21 | 
| 04953170339905 | "PCF-H180AL EVIS EXERA II COLONOSCOPE" | 
| 04953170339899 | OLYMPUS PCF TYPE H180AL | 
| 04953170339882 | "PCF-H180AI EVIS EXERA II ULTRA THIN CLNV" | 
| 04953170339875 | OLYMPUS PCF TYPE H180AI | 
| 04953170339653 | CF-H180DL EVIS EXERA II COLONOSCOPE | 
| 04953170339639 | OLYMPUS CF TYPE H180DI | 
| 04953170339615 | CF-H180AL EVIS EXERA II HD COLONOSCOPE | 
| 04953170339608 | OLYMPUS CF TYPE H180AL | 
| 04953170339592 | CF-H180AI EVIS EXERA II HD COLONOSCOPE | 
| 04953170339585 | OLYMPUS CF TYPE H180AI | 
| 04953170339189 | "PCF-Q180AL EVIS EXERA II COLONOSCOPE" | 
| 04953170339172 | "PCF-Q180AI EVIS EXERA II COLONOSCOPE" | 
| 04953170307720 | OLYMPUS PCF TYPE Q180AL | 
| 04953170307713 | OLYMPUS PCF TYPE Q180AI | 
| 04953170307706 | OLYMPUS CF TYPE Q180AL | 
| 04953170307690 | OLYMPUS CF TYPE Q180AI | 
| 04953170237300 | OLYMPUS PCF TYPE H180AI | 
| 04953170237294 | OLYMPUS PCF TYPE H180AL | 
| 04953170237287 | OLYMPUS PCF TYPE H180AL | 
| 04953170202544 | OLYMPUS PCF TYPE Q180AL | 
| 04953170202506 | OLYMPUS CF TYPE H180AI | 
| 04953170202445 | OLYMPUS CF TYPE H180AL | 
| 04953170202339 | OLYMPUS CF TYPE H180AL | 
| 04953170202315 | OLYMPUS CF TYPE Q180AL |