Catalog Number

-

Brand Name

MANUKAhd Lite Border 10 x 10 cm

Version/Model Number

MM0032

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 31, 2021

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

K102659,K102659

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

e57eb59f-7aed-4313-942f-e755d785f8e0

Public Version Date

November 01, 2021

Public Version Number

3

DI Record Publish Date

January 28, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-