Catalog Number

-

Brand Name

Guedel Oral Airway

Version/Model Number

7-4051

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

CAE

Product Code Name

Airway, Oropharyngeal, Anesthesiology

Public Device Record Key

b5bf2fd7-4920-44c2-ac62-48e9957af475

Public Version Date

October 28, 2019

Public Version Number

1

DI Record Publish Date

October 18, 2019

Package DI Number

10709078007887

Quantity per Package

50

Contains DI Package

00709078007880

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-