Catalog Number

-

Brand Name

Quality Choice

Version/Model Number

BUSQCSMXS48

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)

Yes

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

f2e8e29b-5633-4f2a-a18a-140181c03dd9

Public Version Date

June 09, 2020

Public Version Number

1

DI Record Publish Date

June 01, 2020

Package DI Number

10635515995557

Quantity per Package

6

Contains DI Package

00635515995550

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE