Savvy Mask® Level 3 Surgical Face Mask - The Savvy Surgical Face Mask is a disposable, - Texas Medplast, LLC

Duns Number:117718048

Device Description: The Savvy Surgical Face Mask is a disposable, single-use surgical mask. The surgical face The Savvy Surgical Face Mask is a disposable, single-use surgical mask. The surgical face masks are nonsterile, 3 layers, flat-pleated style. The outer and inner layers of the face masks consist of a thermal bonded bi-component - polyethylene/polyester nonwoven fabric. The middle layer consists of a melt blown polypropylene filter material. Each mask contains ear loops to secure the mask to the user’s face and mouth, as well as a fully enclosed, soft, bendable nosepiece to fit over the nose. This device is not made from natural rubber latex

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Savvy Mask® Level 3 Surgical Face Mask

Version/Model Number

SM01

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K213406,K213406

Product Code Details

Product Code

FXX

Product Code Name

Mask, Surgical

Device Record Status

Public Device Record Key

1602f426-f2dc-4229-8f09-42ead529369b

Public Version Date

June 27, 2022

Public Version Number

2

DI Record Publish Date

April 22, 2022

Additional Identifiers

Package DI Number

10850025566138

Quantity per Package

40

Contains DI Package

00850025566131

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"TEXAS MEDPLAST, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2