Colibri micro-ENT Scope ERW-0200

GUDID 17290016539223

Colibri micro ENT scope is intended to visualize the internal cavities of the ear, airways, nose and sinus cavities during diagnostic and therapeutic endoscope procedures.

3NT MEDICAL LTD

Rigid video otorhinolaryngoscope Rigid video otorhinolaryngoscope Rigid video otorhinolaryngoscope Rigid video otorhinolaryngoscope Rigid video otorhinolaryngoscope Rigid video otorhinolaryngoscope Rigid video otorhinolaryngoscope Rigid video otorhinolaryngoscope Rigid video otorhinolaryngoscope Rigid video otorhinolaryngoscope Rigid video otorhinolaryngoscope Rigid video otorhinolaryngoscope Rigid video otorhinolaryngoscope Rigid video otorhinolaryngoscope Rigid video otorhinolaryngoscope Rigid video otorhinolaryngoscope Rigid video otorhinolaryngoscope
Primary Device ID17290016539223
NIH Device Record Keyd50da817-2a6c-4bfa-a293-fbf77ab3a614
Commercial Distribution StatusIn Commercial Distribution
Brand NameColibri micro-ENT Scope
Version Model NumberERW-0200
Catalog NumberERW-0200
Company DUNS600235289
Company Name3NT MEDICAL LTD
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Angle20 degree
Angle20 degree
Angle20 degree
Angle20 degree
Angle20 degree
Angle20 degree
Angle20 degree
Angle20 degree
Angle20 degree
Angle20 degree
Angle20 degree
Angle20 degree
Angle20 degree
Angle20 degree
Angle20 degree
Angle20 degree
Angle20 degree

Device Identifiers

Device Issuing AgencyDevice ID
GS107290016539226 [Primary]
GS117290016539223 [Package]
Contains: 07290016539226
Package: 10 Pack [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EOBNasopharyngoscope (Flexible Or Rigid)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-08
Device Publish Date2023-12-31

Devices Manufactured by 3NT MEDICAL LTD

17290016539223 - Colibri micro-ENT Scope2024-01-08Colibri micro ENT scope is intended to visualize the internal cavities of the ear, airways, nose and sinus cavities during diagnostic and therapeutic endoscope procedures.
17290016539223 - Colibri micro-ENT Scope2024-01-08 Colibri micro ENT scope is intended to visualize the internal cavities of the ear, airways, nose and sinus cavities during diagn
07290016539073 - Peregrine drivable ENT scope2023-12-19 The Peregrine Drivable ENT Scope is intended to visualize the internal cavities of the ear, airways, nose and sinus cavities dur
07290016539202 - 3NT Video Console 22021-03-01 The 3NT Video Console is used to display the video image received from 3NT Medical endoscopes.
07290016539097 - 3NT Video Console2021-02-22 The 3NT Video Console is used to display the video image received from 3NT Medical endoscopes.

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