Catalog Number

-

Brand Name

McGRATH

Version/Model Number

X3-003-000

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

0f07d381-aae4-478a-a3ca-8ea8d3bf3f5e

Public Version Date

June 01, 2022

Public Version Number

15

DI Record Publish Date

May 22, 2021

Package DI Number

15060272980082

Quantity per Package

10

Contains DI Package

35060272980086

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK