Catalog Number

1-EFA3.5

Brand Name

EXACTA Flow-lc

Version/Model Number

Shade A3.5

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

-

Product Code

EBC

Product Code Name

Sealant, Pit And Fissure, And Conditioner

Public Device Record Key

46e001a5-192a-4503-8e57-dbfbedbe2161

Public Version Date

November 19, 2018

Public Version Number

1

DI Record Publish Date

October 17, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-