PENTAX Medical
GUDID 04961333356393
PENTAX Medical Video Upper GI Scope EG27-i20c
HOYA CORPORATION
Flexible video gastroscope, reusable| Primary Device ID | 04961333356393 |
| NIH Device Record Key | 964882e7-ab51-4365-a32e-dcbe553d00d1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PENTAX Medical |
| Version Model Number | EG27-i20c |
| 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 | 04961333254644 [Primary] |
| GS1 | 04961333356393 [Direct Marking] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K241213
FDA Product Code
| FDS | Gastroscope And Accessories, Flexible/Rigid |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04961333356393]
High-level Disinfectant;Liquid Chemical
[04961333356393]
High-level Disinfectant;Liquid Chemical
[04961333356393]
High-level Disinfectant;Liquid Chemical
[04961333356393]
High-level Disinfectant;Liquid Chemical
[04961333356393]
High-level Disinfectant;Liquid Chemical
[04961333356393]
High-level Disinfectant;Liquid Chemical
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-23 |
| Device Publish Date | 2024-12-13 |
On-Brand Devices [PENTAX Medical]
| 04961333225804 | EPK-i5010 |
| 04961333225408 | VNL15-J10 |
| 04961333225354 | VNL8-J10 |
| 04961333225316 | VNL11-J10 |
| 04961333223794 | EPK-i7010 |
| 04961333246274 | PENTAX Medical Camera Head PVK-J10 |
| 04961333246083 | PENTAX Medical Video Esophagoscope EE17-J10 |
| 04961333246236 | Single Use, Sterile Distal End Cap with Elevator OE-A65 |
| 04961333232994 | Single Use, Sterile Distal End Cap with Elevator OE-A63 |
| 04961333232963 | PENTAX Medical Single Use, Non-Sterile Distal End Cap OE-A62 |
| 04961333221677 | PENTAX Medical PROfILE Single-Use Cleaning Brush |
| 14961333221636 | PENTAX Medical PROfILE Single-Use Cleaning Brush |
| 14961333221575 | PENTAX Medical PROfILE Single-Use Cleaning Brush |
| 84961333253940 | PENTAX Medical Single Use Balloon OE-A61 |
| 04961333246472 | PENTAX Medical Single Round-Trip Carrying Case VF-B22 |
| 04961333246465 | PENTAX Medical Single Round-Trip Carrying Case VF-B21 |
| 04961333239429 | PENTAX Medical O-Ring Set OF-B219 |
| 04961333239399 | PENTAX Medical Cleaning Adapter OE-B10 |
| 04961333237579 | PENTAX Medical Single Round-Trip Carrying Case VE-G26 |
| 04961333237562 | PENTAX Medical Ventilating Connector Adapter OE-C29 |
| 04961333233557 | PENTAX Medical Keyboard EN OS-A111 |
| 04961333232130 | PENTAX Medical Round-Trip Carrying Case VE-B24 |
| 04961333230709 | PENTAX Medical Single Round-Trip Carrying Case VE-G25 |
| 04961333230662 | PENTAX Medical Single Round-Trip Carrying Case VE-B22 |
| 04961333222223 | PENTAX Medical Scanning Unit Connector Soaking Cap OE-U4 |
| 04961333222216 | PENTAX Medical Cleaning Adapter OE-B11 |
| 84961333221666 | PENTAX Medical PROfILE Single-Use Cleaning Brush |
| 04961333221646 | PENTAX Medical PROfILE Single-Use Cleaning Brush |
| 04961333221622 | PENTAX Medical PROfILE Single-Use Cleaning Brush |
| 04961333221608 | PENTAX Medical PROfILE Single-Use Cleaning Brush |
| 04961333221585 | PENTAX Medical PROfILE Single-Use Cleaning Brush |
| 04961333221455 | PENTAX Medical O Ring Set OF-B214 |
| 04961333221448 | PENTAX Medical Cleaning Adapter OF-B212 |
| 04961333221073 | Leakage test adapter OE-B9 |
| 04961333221660 | PENTAX Medical PROfILE Single-Use Cleaning Brush |
| 14961333221629 | PENTAX Medical PROfILE Single-Use Cleaning Brush |
| 14961333221582 | PENTAX Medical PROfILE Single-Use Cleaning Brush |
| 04961333247462 | PENTAX Medical Keyboard EN OS-A115 |
| 84961333221598 | PENTAX Medical PROfILE Single-Use Cleaning Brush |
| 04961333252114 | PENTAX Medical Suction Control Valve OE-B13 |
| 04961333252107 | PENTAX Medical Air/Water Feeding Valve OE-B12 |
| 04961333251841 | PENTAX Medical Water Jet Channel Cleaning Adapter OE-C31 |
| 04961333251834 | PENTAX Medical Cylinder Cleaning Adapter OE-B16 |
| 04961333251827 | PENTAX Medical Air/Water Channel Cleaning Adapter OE-B15 |
| 04961333251650 | PENTAX Medical Keyboard EN OS-A116 |
| 04961333252121 | PENTAX Medical Gas/Water Feeding Valve OE-B14 |
| 04961333251025 | PENTAX Water Bottle Assembly |
| 04961333251636 | PENTAX Medical Keyboard EN OS-A94 |
| 04961333251605 | Keyboard For EPK-i7000 OS-A83 |
| 04961333356331 | PENTAX Medical Video Duodenoscope ED34-i10T2s |
Trademark Results [PENTAX Medical]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PENTAX MEDICAL 79152330 4792478 Live/Registered |
HOYA CORPORATION 2014-02-26 |
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