Catalog Number

880-00

Brand Name

Flexi-Flow Auto

Version/Model Number

880-00

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K922249

Product Code

EMA

Product Code Name

CEMENT, DENTAL

Public Device Record Key

d5756deb-3a58-4bf7-ad1c-7055f3481b22

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-