Catalog Number

-

Brand Name

MANUKAtex 10 x 12.5 cm

Version/Model Number

MM0010

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"

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

K110042,K110042

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

64126cf5-0100-42f8-861c-16fa95bbe711

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

May 14, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-