VIDEO GASTROSCOPE

GUDID 04961333244676

VIDEO GASTROSCOPE - PTAH

PENTAX OF AMERICA, INC.

Flexible video gastroscope Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable
Primary Device ID04961333244676
NIH Device Record Keye25f0ab4-8f1c-4fa9-abdc-1be3a5113085
Commercial Distribution StatusIn Commercial Distribution
Brand NameVIDEO GASTROSCOPE
Version Model NumberEG27-V10C
Company DUNS083211284
Company NamePENTAX OF AMERICA, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS104961333244676 [Primary]

FDA Product Code

FDSGastroscope And Accessories, Flexible/Rigid

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04961333244676]

Ethylene Oxide;High-level Disinfectant


[04961333244676]

Ethylene Oxide;High-level Disinfectant


[04961333244676]

Ethylene Oxide;High-level Disinfectant


[04961333244676]

Ethylene Oxide;High-level Disinfectant


[04961333244676]

Ethylene Oxide;High-level Disinfectant


[04961333244676]

Ethylene Oxide;High-level Disinfectant


[04961333244676]

Ethylene Oxide;High-level Disinfectant


[04961333244676]

Ethylene Oxide;High-level Disinfectant


[04961333244676]

Ethylene Oxide;High-level Disinfectant


[04961333244676]

Ethylene Oxide;High-level Disinfectant


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-04-26
Device Publish Date2018-03-26

On-Brand Devices [VIDEO GASTROSCOPE]

04961333244683VIDEO GASTROSCOPE - PTAH
04961333244676VIDEO GASTROSCOPE - PTAH
04961333244591VIDEO GASTROSCOPE - PTAH (USED)
04961333244584VIDEO GASTROSCOPE - PTAH (USED)
04961333242917VIDEO GASTROSCOPE
04961333240173VIDEO GASTROSCOPE (USED)
04961333240166VIDEO GASTROSCOPE VERSION-C (USED)
04961333240159VIDEO GASTROSCOPE (USED)
04961333232574VIDEO GASTROSCOPE 3.8C 2.8C 12.8T FWJ (REFURBISHED)
04961333232543VIDEO GASTROSCOPE 3.8C 11.6T 1050L FWJ (REFURBISHED)
04961333232536VIDEO GASTROSCOPE - I10 STANDARD (REFURBISHED)
04961333232529VIDEO GASTROSCOPE 2.8C 9.8T 1050L (REFURBISHED)
04961333232512HD VIDEO GASTROSCOPE 2.8C 9.8T 1050L (REFURBISHED)
04961333232505VIDEO GASTROSCOPE (REFURBISHED)
04961333232499VIDEO GASTROSCOPE (REFURBISHED)
04961333232482VIDEO GASTROSCOPE - I10 SLIM (REFURBISHED)
04961333232475VIDEO GASTROSCOPE 2.8C 9.0T 1050L (REFURBISHED)
04961333232468HD VIDEO GASTROSCOPE 2.8C 9.0T 1050L (REFURBISHED)
04961333232451VIDEO GASTROSCOPE 2.4C 8.0T 1050L (REFURBISHED)
04961333232444VIDEO GASTROSCOPE 2.0C 5.4T 1050L (REFURBISHED)

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