IRRIGATOR/INSUFFLATOR

GUDID 04961333242993

PUMP HEAD, EGA-500P

PENTAX OF AMERICA, INC.

Surgical fluid/gas irrigator
Primary Device ID04961333242993
NIH Device Record Key1a85881d-d7ac-4ffe-a902-03773c766e4c
Commercial Distribution StatusIn Commercial Distribution
Brand NameIRRIGATOR/INSUFFLATOR
Version Model NumberEGA-7016
Company DUNS083211284
Company NamePENTAX OF AMERICA, INC.
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS104961333242993 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OCXEndoscopic Irrigation/Suction System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-03-12

On-Brand Devices [IRRIGATOR/INSUFFLATOR]

04961333242993PUMP HEAD, EGA-500P
04961333242986FOOT PEDAL, EGA-500P
04961333242979POWER CORD, EGA-500P/EGA-501P
04961333242962YOKE ADAPTER, EGA-501P
04961333242955HIGH PRESSURE HOSE 3FT, EGA-501P
04961333242948WATERBOTTLE HOLDER
04961333242931PENTAX MEDICAL CO2 INSUFFLATOR
04961333242924PENTAX MEDICAL IRRIGATION PUMP
04961333241781CO2 TUBING, EGA-501P, 10/PKG
04961333241729IRRIG TUBING, EGA-500P, 10/PKG

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