Catalog Number

WRAP-648

Brand Name

Gelzone Wrap

Version/Model Number

15cm x122cm (6 in x 48 in)

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

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

K013732

Product Code

MDA

Product Code Name

Elastomer, Silicone, For Scar Management

Public Device Record Key

6fbd4611-f9df-4445-b2f2-c040a36e422c

Public Version Date

June 30, 2021

Public Version Number

2

DI Record Publish Date

April 30, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-