Catalog Number

900012

Brand Name

CUSTOMED

Version/Model Number

712057200012

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K902271,K902271

Product Code

HHD

Product Code Name

Pad, Menstrual, Unscented

Public Device Record Key

08ea62cb-13c9-4349-8c71-04216eb04b2c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

M2089000122

Quantity per Package

4

Contains DI Package

M2089000120

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

4/CS