Catalog Number

GCIPKA

Brand Name

Quala

Version/Model Number

GCIPKA

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

b0b8f1ff-53ac-47a0-87b0-a486f36b8509

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

February 13, 2017

Package DI Number

D023GCIPKA5

Quantity per Package

500

Contains DI Package

D023GCIPKA3

Package Discontinue Date

-

Package Status

-

Package Type

Case