EndoMask Essential® - Size #2, Single-use PVC Laryngeal Mask - MERLYN ASSOCIATES, INC.

Duns Number:606864184

Device Description: Size #2, Single-use PVC Laryngeal Mask EndoMask Essential® offers the same high qualit

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More Product Details

Catalog Number

300020

Brand Name

EndoMask Essential®

Version/Model Number

Size #2 - 300020

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"

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 Details

Product Code

CAE

Product Code Name

Airway, Oropharyngeal, Anesthesiology

Device Record Status

Public Device Record Key

da4f48bd-d954-4eee-bb4e-c7e410b6b032

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 30, 2017

Additional Identifiers

Package DI Number

10182151000720

Quantity per Package

5

Contains DI Package

00182151000723

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"MERLYN ASSOCIATES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 16
2 A medical device with a moderate to high risk that requires special controls. 54