| Primary Device ID | 04961333237654 | 
| NIH Device Record Key | 983b20c5-c893-4a55-a290-a8aaabfc167a | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | IMAGINA | 
| Version Model Number | EC34-i10cL | 
| Company DUNS | 691519705 | 
| Company Name | HOYA CORPORATION | 
| 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 | true | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 04961333237654 [Direct Marking] | 
| GS1 | 04961333247394 [Primary] | 
| FDF | Colonoscope and accessories, flexible/rigid | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[04961333237654]
High-level Disinfectant;Liquid Chemical
[04961333237654]
High-level Disinfectant;Liquid Chemical
[04961333237654]
High-level Disinfectant;Liquid Chemical
[04961333237654]
High-level Disinfectant;Liquid Chemical
[04961333237654]
High-level Disinfectant;Liquid Chemical
[04961333237654]
High-level Disinfectant;Liquid Chemical
[04961333237654]
High-level Disinfectant;Liquid Chemical
[04961333237654]
High-level Disinfectant;Liquid Chemical
[04961333237654]
High-level Disinfectant;Liquid Chemical
[04961333237654]
High-level Disinfectant;Liquid Chemical
[04961333237654]
High-level Disinfectant;Liquid Chemical
[04961333237654]
High-level Disinfectant;Liquid Chemical
[04961333237654]
High-level Disinfectant;Liquid Chemical
[04961333237654]
High-level Disinfectant;Liquid Chemical
[04961333237654]
High-level Disinfectant;Liquid Chemical
[04961333237654]
High-level Disinfectant;Liquid Chemical
[04961333237654]
High-level Disinfectant;Liquid Chemical
[04961333237654]
High-level Disinfectant;Liquid Chemical
[04961333237654]
High-level Disinfectant;Liquid Chemical
[04961333237654]
High-level Disinfectant;Liquid Chemical
[04961333237654]
High-level Disinfectant;Liquid Chemical
[04961333237654]
High-level Disinfectant;Liquid Chemical
[04961333237654]
High-level Disinfectant;Liquid Chemical
[04961333237654]
High-level Disinfectant;Liquid Chemical
[04961333237654]
High-level Disinfectant;Liquid Chemical
[04961333237654]
High-level Disinfectant;Liquid Chemical
[04961333237654]
High-level Disinfectant;Liquid Chemical
[04961333237654]
High-level Disinfectant;Liquid Chemical
[04961333237654]
High-level Disinfectant;Liquid Chemical
[04961333237654]
High-level Disinfectant;Liquid Chemical
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2020-07-27 | 
| Device Publish Date | 2020-07-17 | 
| 04961333237869 | EC38-i10cL | 
| 04961333237654 | EC34-i10cL | 
| 04961333237586 | EG29-i10c | 
| 04961333233670 | EPK-i5500c | 
| 04961333248681 | Made in Malaysia | 
| 04961333248513 | Made in Malaysia | 
| 04961333248452 | Made in Malaysia | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  IMAGINA  98243755  not registered Live/Pending | HOYA CORPORATION 2023-10-27 | 
|  IMAGINA  87005975  not registered Dead/Abandoned | Melean, Sofia 2016-04-19 | 
|  IMAGINA  87005975  not registered Dead/Abandoned | Chiquilinas Productions LLC 2016-04-19 | 
|  IMAGINA  87005975  not registered Dead/Abandoned | SOMELCO LLC 2016-04-19 | 
|  IMAGINA  77698878  3786801 Dead/Cancelled | Chaljon, Alberto 2009-03-25 | 
|  IMAGINA  77289973  not registered Dead/Abandoned | Jaraalch, Inc. 2007-09-26 | 
|  IMAGINA  75179664  not registered Dead/Abandoned | Imagina, Inc. 1996-10-10 | 
|  IMAGINA  74674285  2351074 Dead/Cancelled | IP1 CORPORATION 1995-05-15 |