ULTRASOUND GASTROSCOPE

GUDID 04961333232550

RADIAL ULTRASOUND VIDEO GASTROSCOPE 2.4C (REFURBISHED)

PENTAX OF AMERICA, INC.

Flexible ultrasound gastroduodenoscope
Primary Device ID04961333232550
NIH Device Record Keyc2845256-a988-4397-98d4-fe7908efc701
Commercial Distribution StatusIn Commercial Distribution
Brand NameULTRASOUND GASTROSCOPE
Version Model NumberEG-3670URK
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 Batchfalse
Serial Numbertrue
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
GS104961333232550 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODGEndoscopic Ultrasound System, Gastroenterology-Urology

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04961333232550]

Ethylene Oxide;High-level Disinfectant


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-04-06

On-Brand Devices [ULTRASOUND GASTROSCOPE]

04961333233953LINEAR ULTRASOUND VIDEO GASTROSCOPE (REFURBISHED)
04961333232567LINEAR ULTRASOUND VIDEO GASTROSCOPE 3.8C (REFURBISHED)
04961333232550RADIAL ULTRASOUND VIDEO GASTROSCOPE 2.4C (REFURBISHED)

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