IMAGINA
GUDID 04961333248681
Made in Malaysia
HOYA CORPORATION
Flexible video colonoscope, reusable| Primary Device ID | 04961333248681 |
| NIH Device Record Key | bbc14f8c-1c80-4fa9-852a-9a09b1ec6548 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04961333248681 [Direct Marking] |
| GS1 | 04961333248711 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K190805
FDA Product Code
| FDF | Colonoscope and accessories, flexible/rigid |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04961333248681]
High-level Disinfectant;Liquid Chemical
[04961333248681]
High-level Disinfectant;Liquid Chemical
[04961333248681]
High-level Disinfectant;Liquid Chemical
[04961333248681]
High-level Disinfectant;Liquid Chemical
[04961333248681]
High-level Disinfectant;Liquid Chemical
[04961333248681]
High-level Disinfectant;Liquid Chemical
[04961333248681]
High-level Disinfectant;Liquid Chemical
[04961333248681]
High-level Disinfectant;Liquid Chemical
[04961333248681]
High-level Disinfectant;Liquid Chemical
[04961333248681]
High-level Disinfectant;Liquid Chemical
[04961333248681]
High-level Disinfectant;Liquid Chemical
[04961333248681]
High-level Disinfectant;Liquid Chemical
[04961333248681]
High-level Disinfectant;Liquid Chemical
[04961333248681]
High-level Disinfectant;Liquid Chemical
[04961333248681]
High-level Disinfectant;Liquid Chemical
[04961333248681]
High-level Disinfectant;Liquid Chemical
[04961333248681]
High-level Disinfectant;Liquid Chemical
[04961333248681]
High-level Disinfectant;Liquid Chemical
[04961333248681]
High-level Disinfectant;Liquid Chemical
[04961333248681]
High-level Disinfectant;Liquid Chemical
[04961333248681]
High-level Disinfectant;Liquid Chemical
[04961333248681]
High-level Disinfectant;Liquid Chemical
[04961333248681]
High-level Disinfectant;Liquid Chemical
[04961333248681]
High-level Disinfectant;Liquid Chemical
[04961333248681]
High-level Disinfectant;Liquid Chemical
[04961333248681]
High-level Disinfectant;Liquid Chemical
[04961333248681]
High-level Disinfectant;Liquid Chemical
[04961333248681]
High-level Disinfectant;Liquid Chemical
[04961333248681]
High-level Disinfectant;Liquid Chemical
[04961333248681]
High-level Disinfectant;Liquid Chemical
[04961333248681]
High-level Disinfectant;Liquid Chemical
[04961333248681]
High-level Disinfectant;Liquid Chemical
[04961333248681]
High-level Disinfectant;Liquid Chemical
[04961333248681]
High-level Disinfectant;Liquid Chemical
[04961333248681]
High-level Disinfectant;Liquid Chemical
[04961333248681]
High-level Disinfectant;Liquid Chemical
[04961333248681]
High-level Disinfectant;Liquid Chemical
[04961333248681]
High-level Disinfectant;Liquid Chemical
[04961333248681]
High-level Disinfectant;Liquid Chemical
[04961333248681]
High-level Disinfectant;Liquid Chemical
[04961333248681]
High-level Disinfectant;Liquid Chemical
[04961333248681]
High-level Disinfectant;Liquid Chemical
[04961333248681]
High-level Disinfectant;Liquid Chemical
[04961333248681]
High-level Disinfectant;Liquid Chemical
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-22 |
| Device Publish Date | 2020-12-14 |
On-Brand Devices [IMAGINA]
| 04961333237869 | EC38-i10cL |
| 04961333237654 | EC34-i10cL |
| 04961333237586 | EG29-i10c |
| 04961333233670 | EPK-i5500c |
| 04961333248681 | Made in Malaysia |
| 04961333248513 | Made in Malaysia |
| 04961333248452 | Made in Malaysia |
Trademark Results [IMAGINA]
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 |
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