Catalog Number

12245

Brand Name

ri-integral blade with integrated F.O.

Version/Model Number

12245

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

CCW

Product Code Name

Laryngoscope, Rigid

Public Device Record Key

637b8956-02e7-4120-a365-5bdaf3ef4cf0

Public Version Date

February 05, 2021

Public Version Number

1

DI Record Publish Date

January 28, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-