| Primary Device ID | 84961333221598 | 
| NIH Device Record Key | 8f03100b-d6d4-486e-ae38-2999031ac515 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | PENTAX Medical | 
| Version Model Number | CS2037A | 
| Company DUNS | 691519705 | 
| Company Name | HOYA CORPORATION | 
| Device Count | 10 | 
| DM Exempt | true | 
| Pre-market Exempt | true | 
| MRI Safety Status | Labeling does not contain MRI Safety Information | 
| Human Cell/Tissue Product | false | 
| Device Kit | false | 
| Device Combination Product | false | 
| Single Use | true | 
| Lot Batch | true | 
| Serial Number | false | 
| 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 | 04961333221592 [Primary] | 
| GS1 | 84961333221598 [Unit of Use] | 
| MNL | Accessories, Cleaning Brushes, For Endoscope | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2023-09-25 | 
| Device Publish Date | 2023-09-15 | 
| 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 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  PENTAX MEDICAL  79152330  4792478 Live/Registered | HOYA CORPORATION 2014-02-26 |