Catalog Number

PRD500-100

Brand Name

KerraMax Care

Version/Model Number

5 x 6in

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

-

Product Code

NAC

Product Code Name

Dressing, Wound, Hydrophilic

Public Device Record Key

a13cd438-014f-460a-8571-bf527040a3e9

Public Version Date

September 09, 2020

Public Version Number

3

DI Record Publish Date

October 01, 2019

Package DI Number

05060077234314

Quantity per Package

550

Contains DI Package

05060077231573

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper