Catalog Number

1098

Brand Name

Provicol QM Plus

Version/Model Number

1098

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

K161630

Product Code

EMB

Product Code Name

Zinc Oxide Eugenol

Public Device Record Key

bd2b22fc-2eb9-4836-98eb-f9b2f2c7f932

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 31, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-