FDA.reportPublic FDA data

Flexible Video Rhino Laryngoscope

Primary DI
B809M205240310101
Brand
Flexible Video Rhino Laryngoscope
Company
orlvision GmbH
Model
RSX-USB
Catalog number
M-205-24031-0101
Device description
Flexible Video Rhino Laryngoscope
Published
2020-03-06
Public version status
Update
Distribution status
Not 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
B809M205240310101PrimaryHIBCC0

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
DM exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B809M300000003000Video OtoscopeOX2M-300-00000-30002020-03-06
B809M105220300700Laryngoskop FS212020-10-19
B809M205220310101Flexible Video Rhino LaryngoscopeRSX-PM-205-22031-01012020-03-06
B809M2052203101010LaryngoscopeRSX USB PM2052203101012019-11-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B366FE1024RX1Nasopharyngoscope, FlexibleEclerisEQN2025-04-16
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