Catalog Number

FSA-200

Brand Name

FemVue® Saline-Air Device

Version/Model Number

FSA-200

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

Yes

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

K110288

Product Code

LKF

Product Code Name

Cannula, Manipulator/Injector, Uterine

Public Device Record Key

c75600e3-b9f8-40f3-87d6-f4a57337e4a7

Public Version Date

March 20, 2019

Public Version Number

1

DI Record Publish Date

March 12, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-