Catalog Number

-

Brand Name

McGRATH MAC

Version/Model Number

350-005-000

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

158325ea-6ae1-47f5-ad56-6a8f2f296d74

Public Version Date

September 16, 2022

Public Version Number

8

DI Record Publish Date

February 27, 2021

Package DI Number

35060272980352

Quantity per Package

10

Contains DI Package

25060272980355

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE