Catalog Number

Q602340

Brand Name

Quala

Version/Model Number

Q602340

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

FRG

Product Code Name

Wrap, Sterilization

Public Device Record Key

6600ed48-1eaa-4e8d-9315-013663c3c94b

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

February 13, 2017

Package DI Number

D023Q6023403

Quantity per Package

500

Contains DI Package

D023Q6022401

Package Discontinue Date

-

Package Status

-

Package Type

Case