Catalog Number

-

Brand Name

McGRATH MAC

Version/Model Number

301-000-000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

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

f45c4cd4-45c4-48ec-ac5c-22fd01223a78

Public Version Date

January 10, 2022

Public Version Number

6

DI Record Publish Date

April 10, 2021

Package DI Number

30884521776498

Quantity per Package

20

Contains DI Package

10884521776494

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE