Catalog Number

-

Brand Name

Up & Up

Version/Model Number

81236

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

EWD

Product Code Name

Protector, Hearing (Insert)

Public Device Record Key

88bfec86-b32e-419d-b968-3488223c961e

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

March 17, 2021

Package DI Number

20794503812362

Quantity per Package

24

Contains DI Package

00794503812368

Package Discontinue Date

March 11, 2021

Package Status

Not in Commercial Distribution

Package Type

Case