Catalog Number

-

Brand Name

TOPCARE

Version/Model Number

10003430

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HHD

Product Code Name

Pad, Menstrual, Unscented

Public Device Record Key

3351d830-c308-41f5-99df-e206dc9e27da

Public Version Date

August 11, 2020

Public Version Number

1

DI Record Publish Date

August 03, 2020

Package DI Number

10036800316468

Quantity per Package

12

Contains DI Package

00036800316461

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipping Case