Poise - ONE BY POISE SUPRPREM XCVRG FLAT LINER 50 - KIMBERLY-CLARK GLOBAL SALES, INC.

Duns Number:829568273

Device Description: ONE BY POISE SUPRPREM XCVRG FLAT LINER 50

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More Product Details

Catalog Number

-

Brand Name

Poise

Version/Model Number

Pad

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 30, 2022

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

HHD

Product Code Name

Pad, menstrual, unscented

Device Record Status

Public Device Record Key

6e6e1f0e-f3ce-4e7f-b028-57ed9cb1e244

Public Version Date

September 30, 2022

Public Version Number

3

DI Record Publish Date

July 01, 2020

Additional Identifiers

Package DI Number

10036000534488

Quantity per Package

4

Contains DI Package

00036000534481

Package Discontinue Date

September 30, 2022

Package Status

Not in Commercial Distribution

Package Type

Case

"KIMBERLY-CLARK GLOBAL SALES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 28
2 A medical device with a moderate to high risk that requires special controls. 141