Catalog Number

AD3554

Brand Name

Quala

Version/Model Number

AD3554

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

KCT

Product Code Name

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Public Device Record Key

2cb41a78-ad36-416d-baf1-f15875feba34

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

February 13, 2017

Package DI Number

D023AD35543

Quantity per Package

4000

Contains DI Package

D023AD35541

Package Discontinue Date

-

Package Status

-

Package Type

Case