Catalog Number

SS-4506W

Brand Name

Otological Silicone Strips

Version/Model Number

SS-4506W

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

MDA

Product Code Name

Elastomer, Silicone, For Scar Management

Public Device Record Key

0e381bd1-d4ca-4714-9450-2da89f2dc9f1

Public Version Date

August 30, 2022

Public Version Number

3

DI Record Publish Date

September 20, 2015

Package DI Number

EBESSS4506W1

Quantity per Package

10

Contains DI Package

EBESSS4506W0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton