Catalog Number

-

Brand Name

Hydrofera Blue Ready - Border

Version/Model Number

HBRB6080

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K190268,K190268

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

12a3b0b0-93d6-4a46-a071-e5e64d0d4e35

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

December 16, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-