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

31b6d51d-cd4a-45ec-b72a-6a67aca4b283

Public Version Date

January 27, 2022

Public Version Number

4

DI Record Publish Date

March 27, 2021

Package DI Number

65060272980339

Quantity per Package

30

Contains DI Package

55060272980332

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE