Laryngoscope - Video Nasopharyngo-laryngoscope - orlvision GmbH

Duns Number:341467978

Device Description: Video Nasopharyngo-laryngoscope

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More Product Details

Catalog Number

M205220310101

Brand Name

Laryngoscope

Version/Model Number

RSX USB P

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 28, 2020

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K150248

Product Code Details

Product Code

EQN

Product Code Name

Laryngoscope, Nasopharyngoscope

Device Record Status

Public Device Record Key

c4c3d625-a641-4154-a5ac-18a8e6188b1a

Public Version Date

March 09, 2020

Public Version Number

2

DI Record Publish Date

November 19, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ORLVISION GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 4