Laryngoskop FS2

Primary DI
B809M105220300700
Brand
Laryngoskop FS2
Company
orlvision GmbH
Model
1
Device description
This flexible fibre scope is designed with the flexible insertion tube with its bendable distal tip, the handle with the leakage tester and connection for light source port. The handle incorporates the control lever to bend the distal tip. The picture is the region under examination is imaged by an optical unit.
Published
2020-10-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EQNLaryngoscope, Nasopharyngoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EQNLaryngoscope, NasopharyngoscopeEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150248000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150248000ORL Video NasoPharyngo-LarngoscopeJedmed Instrument Company2015-07-23EQN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B809M105220300700PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video nasopharyngoscopeAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the nasopharynx (the upper part of the throat behind the nose). It is inserted through a nostril during ear/nose/throat (ENT) procedures. Anatomical images are transmitted to the user by a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope and the images showing on a monitor. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
341467978
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B809M205240310101Flexible Video Rhino LaryngoscopeRSX-USBM-205-24031-01012020-03-06
B809M300000003000Video OtoscopeOX2M-300-00000-30002020-03-06
B809M205220310101Flexible Video Rhino LaryngoscopeRSX-PM-205-22031-01012020-03-06
B809M2052203101010LaryngoscopeRSX USB PM2052203101012019-11-19

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