Catalog Number

-

Brand Name

SourceMark

Version/Model Number

M0342

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)

-

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

7ef7c226-4cea-47a5-9f9c-28130190b137

Public Version Date

November 16, 2020

Public Version Number

1

DI Record Publish Date

November 06, 2020

Package DI Number

10813799007153

Quantity per Package

5

Contains DI Package

00813799007149

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box