ri-integral blade with integrated F.O. - The laryngoscopes are manufactured in order to be - Rudolf Riester GmbH

Duns Number:537208717

Device Description: The laryngoscopes are manufactured in order to be used for endotracheal intubation.

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More Product Details

Catalog Number

12244

Brand Name

ri-integral blade with integrated F.O.

Version/Model Number

12244

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K945425

Product Code Details

Product Code

CCW

Product Code Name

Laryngoscope, Rigid

Device Record Status

Public Device Record Key

5a8920b0-cb24-4f48-a15e-97086edee564

Public Version Date

February 05, 2021

Public Version Number

1

DI Record Publish Date

January 28, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RUDOLF RIESTER GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 282
2 A medical device with a moderate to high risk that requires special controls. 332