Catalog Number

0114008

Brand Name

Redicare

Version/Model Number

Burn Gel Dressing 4" x 4"

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"

Yes

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

NAE

Product Code Name

Dressing, Wound, Hydrogel Without Drug And/Or Biologic

Public Device Record Key

b1abe73e-0ee6-406c-b47a-9a192706385d

Public Version Date

August 24, 2021

Public Version Number

2

DI Record Publish Date

August 25, 2020

Package DI Number

B70901140081

Quantity per Package

120

Contains DI Package

B70901140080

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton