Crosstex International - Advantage earloop mask/PINK - CROSSTEX INTERNATIONAL, INC.

Duns Number:057728685

Device Description: Advantage earloop mask/PINK

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


More Product Details

Catalog Number

GCAPK

Brand Name

Crosstex International

Version/Model Number

GCAPK

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

K133070,K133070

Product Code Details

Product Code

FXX

Product Code Name

Mask, surgical

Device Record Status

Public Device Record Key

bebd8abd-c912-4169-ad54-194708a544b6

Public Version Date

June 19, 2020

Public Version Number

5

DI Record Publish Date

February 11, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CROSSTEX INTERNATIONAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 33
2 A medical device with a moderate to high risk that requires special controls. 25