Catalog Number

-

Brand Name

McGRATH MAC

Version/Model Number

350-082-000

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

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

8ef562f3-55fe-4b79-b701-d45a75bd6281

Public Version Date

February 14, 2022

Public Version Number

1

DI Record Publish Date

February 06, 2022

Package DI Number

30884521824397

Quantity per Package

30

Contains DI Package

20884521824390

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE