VIDEO ESOPHAGOSCOPE

GUDID 04961333232437

VIDEO ESOPHAGOSCOPE (REFURBISHED)

PENTAX OF AMERICA, INC.

Flexible video oesophagoscope, reusable
Primary Device ID04961333232437
NIH Device Record Key8d8ea4b6-740e-4ade-ae88-526903f3ff64
Commercial Distribution StatusIn Commercial Distribution
Brand NameVIDEO ESOPHAGOSCOPE
Version Model NumberEE-1580K
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
GS104961333232437 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FDSGastroscope And Accessories, Flexible/Rigid

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04961333232437]

Ethylene Oxide;High-level Disinfectant


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2017-04-06

Devices Manufactured by PENTAX OF AMERICA, INC.

04961333255016 - LARYNGOSTROBOSCOPE2025-05-05 LARYNGEAL STROBE 9500
04961333255702 - LARYNGOSTROBOSCOPE2025-05-05 9500LX, Laryngeal Microphone "Accessory for 9500"
04961333255719 - LARYNGOSTROBOSCOPE2025-05-05 9500MC, Lapel Microphone "Accessory for 9500"
04961333255726 - LARYNGOSTROBOSCOPE2025-05-05 9500FS, Footswitch "Accessory for 9500 "
00854924006255 - C2 CryoBalloon Ablation System 2025-04-14 Gen 2 360 Degree Pear Catheter
00854924006293 - C2 CryoBalloon Ablation System2025-04-14 Gen 2 360 Degree Standard Catheter
04961333255313 - C2 CryoBalloon2024-09-20
04961333255320 - C2 CryoBalloon2024-09-20

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.