Catalog Number

-

Brand Name

Shiley

Version/Model Number

33730

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

46def1cf-47d9-41e0-8ace-ed191c2fdddb

Public Version Date

July 22, 2022

Public Version Number

3

DI Record Publish Date

September 20, 2018

Package DI Number

20884521198859

Quantity per Package

10

Contains DI Package

10884521198852

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK