Catalog Number

-

Brand Name

SoftFlow

Version/Model Number

SF-W

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

EGD

Product Code Name

Wax, Dental, Intraoral

Public Device Record Key

ef0b2a1d-ef6a-4ea2-b81e-78e175712fd4

Public Version Date

November 20, 2019

Public Version Number

2

DI Record Publish Date

February 27, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-