Catalog Number

-

Brand Name

Flents

Version/Model Number

F414-405

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

NAD

Product Code Name

Dressing, Wound, Occlusive

Public Device Record Key

c6c7aff5-64d8-4597-85ba-32ca9d5cc18d

Public Version Date

October 21, 2020

Public Version Number

1

DI Record Publish Date

October 13, 2020

Package DI Number

20023185144059

Quantity per Package

6

Contains DI Package

00023185144055

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

inner