Catalog Number

-

Brand Name

Flents

Version/Model Number

65200

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

-

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

HED

Product Code Name

Douche Apparatus, Vaginal, Therapeutic

Public Device Record Key

b0e2f920-047a-45de-9747-6a0f246a47cb

Public Version Date

November 24, 2020

Public Version Number

1

DI Record Publish Date

November 16, 2020

Package DI Number

10025715040742

Quantity per Package

12

Contains DI Package

00025715652009

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case