UNIWEB SURGICAL MASK - The Surgical Mask is intended to be worn to - UNIVERSAL INCORPORATION

Duns Number:656249554

Device Description: The Surgical Mask is intended to be worn to protect both the patient and healthcare person The Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. This device is intended for adult use Only. The UNIWEB Surgical Masks are single use, disposable device, provided non-sterile.

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More Product Details

Catalog Number

-

Brand Name

UNIWEB SURGICAL MASK

Version/Model Number

ASTM Level 2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

K210513,K210513,K210513

Product Code Details

Product Code

FXX

Product Code Name

Mask, Surgical

Device Record Status

Public Device Record Key

48cfb111-0c1b-445a-a136-716ebcf0523e

Public Version Date

January 11, 2022

Public Version Number

1

DI Record Publish Date

January 03, 2022

Additional Identifiers

Package DI Number

14715243610147

Quantity per Package

40

Contains DI Package

04715243610140

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

40Boxes/Carton