SourceMark - SOURCEMARK, LLC.

Duns Number:121225812

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More Product Details

Catalog Number

-

Brand Name

SourceMark

Version/Model Number

M0373

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

CAE

Product Code Name

Airway, Oropharyngeal, Anesthesiology

Device Record Status

Public Device Record Key

2c723454-66ee-4899-b127-a8ac644d453b

Public Version Date

November 16, 2020

Public Version Number

1

DI Record Publish Date

November 06, 2020

Additional Identifiers

Package DI Number

10813799007603

Quantity per Package

5

Contains DI Package

00813799007590

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"SOURCEMARK, LLC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 24
2 A medical device with a moderate to high risk that requires special controls. 71