VIDEO BRONCHOSCOPE

GUDID 04961333232178

VIDEO BRONCHOSCOPE (REFURBISHED)

PENTAX OF AMERICA, INC.

Flexible video bronchoscope, reusable
Primary Device ID04961333232178
NIH Device Record Key197ea635-c7d0-4cb5-954f-2a48ed359a9c
Commercial Distribution StatusIn Commercial Distribution
Brand NameVIDEO BRONCHOSCOPE
Version Model NumberEB-1575K
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
GS104961333232178 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EOQBronchoscope (Flexible Or Rigid)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04961333232178]

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 BRONCHOSCOPE]

04961333240081VIDEO BRONCHOSCOPE (USED)
04961333240074VIDEO BRONCHOSCOPE (USED)
04961333232222I SERIES HD VIDEO BRONCHOSCOPE (REFURBISHED)
04961333232215VIDEO BRONCHOSCOPE (REFURBISHED)
04961333232192VIDEO BRONCHOSCOPE 3.2C 6.2TP 600L (REFURBISHED)
04961333232185VIDEO BRONCHOSCOPE (REFURBISHED)
04961333232178VIDEO BRONCHOSCOPE (REFURBISHED)
04961333232161VIDEO BRONCHOSCOPE (REFURBISHED)
04961333232154VIDEO BRONCHOSCOPE 1.2C 3.8TP 600L (REFURBISHED)

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