Catalog Number

-

Brand Name

Omni Integrated Single Use Laryngoscope Handle Miller Blade Size 1.5

Version/Model Number

040-04-0415U

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

CCW

Product Code Name

Laryngoscope, Rigid

Public Device Record Key

ee108f43-9d6b-43d4-b8a5-5518dd60303e

Public Version Date

March 13, 2020

Public Version Number

1

DI Record Publish Date

March 05, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-