Catalog Number

PRD500-600

Brand Name

KerraMax Care

Version/Model Number

8 x 20in

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

c7c0480f-f4be-4c6c-9a0e-0ccd5fb29de8

Public Version Date

September 09, 2020

Public Version Number

3

DI Record Publish Date

October 01, 2019

Package DI Number

05060077234369

Quantity per Package

15

Contains DI Package

05060077234352

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper