Flexible Video Rhino Laryngoscope - Flexible Video Rhino Laryngoscope - orlvision GmbH

Duns Number:341467978

Device Description: Flexible Video Rhino Laryngoscope

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More Product Details

Catalog Number

M-205-24031-0101

Brand Name

Flexible Video Rhino Laryngoscope

Version/Model Number

RSX-USB

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

December 31, 2025

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

253c2c6c-77fe-4034-b340-0408b148cb49

Public Version Date

March 16, 2020

Public Version Number

1

DI Record Publish Date

March 06, 2020

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