VIDEO COLONOSCOPE

GUDID 04961333232253

HDVIDEO COLONOSCOPE 3.2C 11.6T 1700L FWJ (REFURBISHED)

PENTAX OF AMERICA, INC.

Flexible video colonoscope, reusable
Primary Device ID04961333232253
NIH Device Record Key2884cd20-6a5c-4e18-afa6-505173a598c1
Commercial Distribution StatusIn Commercial Distribution
Brand NameVIDEO COLONOSCOPE
Version Model NumberEC-3490LI
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
GS104961333232253 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FDFColonoscope And Accessories, Flexible/Rigid

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04961333232253]

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 COLONOSCOPE]

04961333244669VIDEO COLONOSCOPE - PTAH
04961333244652VIDEO COLONOSCOPE - PTAH
04961333244577VIDEO COLONOSCOPE - PTAH (USED)
04961333244560VIDEO COLONOSCOPE - PTAH (USED)
04961333244553VIDEO COLONOSCOPE (USED)
04961333242900VIDEO COLONOSCOPE
04961333240104VIDEO COLONOSCOPE (USED)
04961333240098VIDEO COLONOSCOPE (USED)
04961333232383VIDEO COLONOCOPE - I10 STANDARD (REFURBISHED)
04961333232376VIDEO COLONOSCOPE 3.8C 2.8C 13.2T FWJ (REFURBISHED)
04961333232369MAGNIVIEW VIDEO COLONOSCOPE (REFURBISHED)
04961333232352VIDEO COLONOSCOPE 4.2C 13.2T 1700L FWJ (REFURBISHED)
04961333232345HDVIDEO COLONOSCOPE 3.8C 13.2T 1700L FWJ (REFURBISHED)
04961333232338VIDEO COLONOSCOPE 3.8C 13.2T FWJ ZOOM (REFURBISHED)
04961333232321VIDEO COLONOSCOPE WITH ZOOM (REFURBISHED)
04961333232314VIDEO COLONOSCOPE CD3.8MM (REFURBISHED)
04961333232307VIDEO COLONOSCOPE (REFURBISHED)
04961333232291VIDEO COLONOSCOPE - CLASSIC LINE (REFURBISHED)
04961333232284VIDEO COLONOSCOPE - I10 SLIM (REFURBISHED)
04961333232277RETROVIEW VIDEO COLONOSCOPE (REFURBISHED)
04961333232260VIDEO COLONOSCOPE 3.8C 11.6T 1700L FWJ (REFURBISHED)
04961333232253HDVIDEO COLONOSCOPE 3.2C 11.6T 1700L FWJ (REFURBISHED)
04961333232246VIDEO COLONOSCOPE SD11.7,CD3.5,FWJ (REFURBISHED)
04961333232239HDVIDEO COLONOSCOPE 2.8C 9.8T 1700L FWJ (REFURBISHED)
04961333225613VIDEO COLONOSCOPE
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.