Catalog Number

-

Brand Name

Wrap-Ease™ Cushions

Version/Model Number

BWWEL

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K852170,K852170,K852170

Product Code

EGZ

Product Code Name

Holder, film, x-ray

Public Device Record Key

58490e74-1228-4379-9bd1-a059e917928e

Public Version Date

October 07, 2022

Public Version Number

1

DI Record Publish Date

September 29, 2022

Package DI Number

50732224003066

Quantity per Package

12

Contains DI Package

10732224003068

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-