Catalog Number

-

Brand Name

Bite Wing-Ease™ Barrier Sleeves

Version/Model Number

BWES

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

bfaf69a7-295a-419d-80d9-e5d1782f56c0

Public Version Date

October 07, 2022

Public Version Number

1

DI Record Publish Date

September 29, 2022

Package DI Number

50732224002991

Quantity per Package

12

Contains DI Package

10732224002993

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-