Catalog Number

-

Brand Name

Femcare

Version/Model Number

FN-100-212

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"

Yes

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

-

Product Code

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Public Device Record Key

18db1b48-58b7-497e-8329-7e3e10b66efb

Public Version Date

February 17, 2020

Public Version Number

4

DI Record Publish Date

August 15, 2019

Package DI Number

24714127864970

Quantity per Package

5

Contains DI Package

14714127864973

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-