PENTAX MEDICAL

GUDID 04961333223794

HOYA CORPORATION

Endoscopic video image processing unit
Primary Device ID04961333223794
NIH Device Record Key8d1e277b-b31d-4cb1-93ca-86e94dbf2c0f
Commercial Distribution StatusIn Commercial Distribution
Brand NamePENTAX MEDICAL
Version Model NumberEPK-i7010
Company DUNS691519705
Company NameHOYA CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104961333221141 [Direct Marking]
GS104961333223794 [Primary]

FDA Product Code

PEAEndoscope, accessories, image post-processing for color enhancement

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-21
Device Publish Date2017-04-07

On-Brand Devices [PENTAX MEDICAL]

04961333225804EPK-i5010
04961333225408VNL15-J10
04961333225354VNL8-J10
04961333225316VNL11-J10
04961333223794EPK-i7010
04961333246274PENTAX Medical Camera Head PVK-J10
04961333246083PENTAX Medical Video Esophagoscope EE17-J10
04961333246236Single Use, Sterile Distal End Cap with Elevator OE-A65
04961333232994Single Use, Sterile Distal End Cap with Elevator OE-A63
04961333232963PENTAX Medical Single Use, Non-Sterile Distal End Cap OE-A62
04961333221677PENTAX Medical PROfILE Single-Use Cleaning Brush
14961333221636PENTAX Medical PROfILE Single-Use Cleaning Brush
14961333221575PENTAX Medical PROfILE Single-Use Cleaning Brush
84961333253940PENTAX Medical Single Use Balloon OE-A61
04961333246472PENTAX Medical Single Round-Trip Carrying Case VF-B22
04961333246465PENTAX Medical Single Round-Trip Carrying Case VF-B21
04961333239429PENTAX Medical O-Ring Set OF-B219
04961333239399PENTAX Medical Cleaning Adapter OE-B10
04961333237579PENTAX Medical Single Round-Trip Carrying Case VE-G26
04961333237562PENTAX Medical Ventilating Connector Adapter OE-C29
04961333233557PENTAX Medical Keyboard EN OS-A111
04961333232130PENTAX Medical Round-Trip Carrying Case VE-B24
04961333230709PENTAX Medical Single Round-Trip Carrying Case VE-G25
04961333230662PENTAX Medical Single Round-Trip Carrying Case VE-B22
04961333222223PENTAX Medical Scanning Unit Connector Soaking Cap OE-U4
04961333222216PENTAX Medical Cleaning Adapter OE-B11
84961333221666PENTAX Medical PROfILE Single-Use Cleaning Brush
04961333221646PENTAX Medical PROfILE Single-Use Cleaning Brush
04961333221622PENTAX Medical PROfILE Single-Use Cleaning Brush
04961333221608PENTAX Medical PROfILE Single-Use Cleaning Brush
04961333221585PENTAX Medical PROfILE Single-Use Cleaning Brush
04961333221455PENTAX Medical O Ring Set OF-B214
04961333221448PENTAX Medical Cleaning Adapter OF-B212
04961333221073Leakage test adapter OE-B9
04961333221660PENTAX Medical PROfILE Single-Use Cleaning Brush
14961333221629PENTAX Medical PROfILE Single-Use Cleaning Brush
14961333221582PENTAX Medical PROfILE Single-Use Cleaning Brush
04961333247462PENTAX Medical Keyboard EN OS-A115
84961333221598PENTAX Medical PROfILE Single-Use Cleaning Brush
04961333252114PENTAX Medical Suction Control Valve OE-B13
04961333252107PENTAX Medical Air/Water Feeding Valve OE-B12
04961333251841PENTAX Medical Water Jet Channel Cleaning Adapter OE-C31
04961333251834PENTAX Medical Cylinder Cleaning Adapter OE-B16
04961333251827PENTAX Medical Air/Water Channel Cleaning Adapter OE-B15
04961333251650PENTAX Medical Keyboard EN OS-A116
04961333252121PENTAX Medical Gas/Water Feeding Valve OE-B14
04961333251025PENTAX Water Bottle Assembly
04961333251636PENTAX Medical Keyboard EN OS-A94
04961333251605Keyboard For EPK-i7000 OS-A83
04961333356331PENTAX Medical Video Duodenoscope ED34-i10T2s

Trademark Results [PENTAX MEDICAL]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PENTAX MEDICAL
PENTAX MEDICAL
79152330 4792478 Live/Registered
HOYA CORPORATION
2014-02-26
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