Catalog Number

Q055030

Brand Name

Quala

Version/Model Number

Q055030

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K820617,K820617

Product Code

EJJ

Product Code Name

Alloy, Amalgam

Public Device Record Key

6a39f306-c792-4e0e-a148-127c8a9971ca

Public Version Date

September 19, 2022

Public Version Number

3

DI Record Publish Date

February 13, 2017

Package DI Number

D023Q0550303

Quantity per Package

24

Contains DI Package

D023Q0550301

Package Discontinue Date

-

Package Status

-

Package Type

Case