Stayfree - SF ADV CLASSIC WLESS HTA 22 - EDGEWELL PERSONAL CARE BRANDS, LLC

Duns Number:151179769

Device Description: SF ADV CLASSIC WLESS HTA 22

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More Product Details

Catalog Number

-

Brand Name

Stayfree

Version/Model Number

07028

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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 Details

Product Code

HHD

Product Code Name

Pad, menstrual, unscented

Device Record Status

Public Device Record Key

b3460c10-9cd0-49f8-ae34-6a3e34f47929

Public Version Date

May 23, 2019

Public Version Number

2

DI Record Publish Date

April 30, 2019

Additional Identifiers

Package DI Number

00078300029670

Quantity per Package

4

Contains DI Package

00078300070283

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"EDGEWELL PERSONAL CARE BRANDS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 54
2 A medical device with a moderate to high risk that requires special controls. 65