Primary Device ID | 04961333251650 |
NIH Device Record Key | ce0b7a00-0e49-42ae-9da0-022232bcce94 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PENTAX Medical |
Version Model Number | OS-A116 |
Company DUNS | 691519705 |
Company Name | HOYA CORPORATION |
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 | 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 | 04961333251650 [Primary] |
PEA | Endoscope, Accessories, Image Post-Processing For Color Enhancement |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-11-08 |
Device Publish Date | 2023-10-31 |
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 |