Catalog Number

-

Brand Name

Shiley

Version/Model Number

33750

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"

-

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

CAE

Product Code Name

AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY

Public Device Record Key

f13d5235-07f2-4dbe-a3cc-20a6bd0492af

Public Version Date

July 22, 2022

Public Version Number

3

DI Record Publish Date

September 20, 2018

Package DI Number

30884521198870

Quantity per Package

5

Contains DI Package

20884521198873

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE