Catalog Number

66032

Brand Name

Wings

Version/Model Number

66032

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

EYQ

Product Code Name

GARMENT, PROTECTIVE, FOR INCONTINENCE

Public Device Record Key

43041a14-da9f-477c-9070-2510586dab49

Public Version Date

February 15, 2019

Public Version Number

2

DI Record Publish Date

June 30, 2018

Package DI Number

10884527000661

Quantity per Package

96

Contains DI Package

20884527000668

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE