VIDEO CYTOSCOPE

GUDID 04961333232390

VIDEO CYSTOSCOPE (REFURBISHED)

PENTAX OF AMERICA, INC.

Flexible video cystoscope, reusable
Primary Device ID04961333232390
NIH Device Record Key9fdde9a9-6487-41f5-80cf-e8da8567aeb3
Commercial Distribution Discontinuation2017-06-30
Commercial Distribution StatusNot in Commercial Distribution
Brand NameVIDEO CYTOSCOPE
Version Model NumberECY-1530
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
GS104961333232390 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FAJCystoscope And Accessories, Flexible/Rigid

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04961333232390]

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 [VIDEO CYTOSCOPE]

04961333232413VIDEO CYSTOSCOPE (REFURBISHED)
04961333232406VIDEO CYSTOSCOPE 2.0C 5.5TP 400L (REFURBISHED)
04961333232390VIDEO CYSTOSCOPE (REFURBISHED)

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