N/A

GUDID 14961333221438

PENTAX Medical single use suction control valve

HOYA CORPORATION

Endoscopic suction valve, single-use, sterile
Primary Device ID14961333221438
NIH Device Record Keyb3150c04-e6b2-4114-8b5c-93a80ac1530d
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberOF-B205
Company DUNS691519705
Company NameHOYA CORPORATION
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104961333221431 [Unit of Use]
GS114961333221438 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EOBNasopharyngoscope (Flexible Or Rigid)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-01-21
Device Publish Date2018-12-19

On-Brand Devices [N/A]

14961333221650PROfILE Single Use Endoscope Cleaning Brush Kits
14961333221612PROfILE Single Use Endoscope Cleaning Brush Kits
14961333221438PENTAX Medical single use suction control valve
04961333233007ED34-i10T2
04961333234066EC34-i10TL
04961333233991EG34-i10
04961333222162EB19-J10U
04961333239634PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U
04961333239535PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR
04961333239436PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT
04961333221530PENTAX Medical Video Bronchoscope EB19-J10
04961333221486PENTAX Medical Video Bronchoscope EB15-J10
04961333248292Made in Malaysia
04961333248186Made in Malaysia
04961333248155Made in Malaysia
04961333248124Made in Malaysia
04961333248988PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT (Made in Malaysia)
04961333248902PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR (Made in Malaysia)
04961333248827PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U (Made in Malaysia)
04961333245802PENTAX Medical Video Bronchoscope EB11-J10
04961333245987PENTAX Medical Video Upper GI Scope EG17-J10
04961333251315PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL15-J10 (Made in Malaysia, Electronic IFU)
04961333251148PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL11-J10 (Made in Malaysia, Electronic IFU)
04961333221417PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL15-J10 (Electronic IFU)
04961333221370PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL8-J10 (Electronic IFU)
04961333221325PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL11-J10 (Electronic IFU)
04961333246168PENTAX Medical Video Duodenoscope ED32-i10
04961333251575PENTAX Medical Video Bronchoscope EB11-J10 (Made in Malaysia)
04961333251490PENTAX Medical Video Bronchoscope EB19-J10 (Made in Malaysia)
04961333251223"PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL8-J10 (Made in Malaysia, Electronic IFU)

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