Catalog Number

Q-9001HP

Brand Name

Quala

Version/Model Number

Q-9001HP

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

-

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

ELW

Product Code Name

Material, Impression

Public Device Record Key

37ee6cea-12d0-47cd-838c-038297c9635f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 13, 2017

Package DI Number

D023Q9001HP3

Quantity per Package

4

Contains DI Package

D023Q9001HP19

Package Discontinue Date

-

Package Status

-

Package Type

Case