Catalog Number

-

Brand Name

SourceMark

Version/Model Number

M0365

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

3d60ac36-daf0-4969-baf5-b4f9f4560e07

Public Version Date

July 09, 2020

Public Version Number

6

DI Record Publish Date

August 26, 2016

Package DI Number

10897392003620

Quantity per Package

5

Contains DI Package

00897392002381

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box