Catalog Number

-

Brand Name

McGRATH

Version/Model Number

340-000-000

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

959d945f-d4d4-4fc4-89d6-e2a66199076a

Public Version Date

October 15, 2021

Public Version Number

1

DI Record Publish Date

October 07, 2021

Package DI Number

25060272980065

Quantity per Package

25

Contains DI Package

15060272980068

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE