Catalog Number

-

Brand Name

SourceMark

Version/Model Number

M0363

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

-

Prescription Use (Rx)

-

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

16a45b1f-431d-4eae-b009-95406eb2eef6

Public Version Date

July 16, 2020

Public Version Number

1

DI Record Publish Date

July 08, 2020

Package DI Number

10813799003070

Quantity per Package

10

Contains DI Package

00813799003066

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box