Catalog Number

ZF10

Brand Name

Zorflex

Version/Model Number

ZF10

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

-

Product Code

NAC

Product Code Name

Dressing, Wound, Hydrophilic

Public Device Record Key

f262fa4e-bb59-46d2-91bd-1cd4d7ecd4a4

Public Version Date

September 09, 2021

Public Version Number

1

DI Record Publish Date

September 01, 2021

Package DI Number

05060467570008

Quantity per Package

10

Contains DI Package

05060467570138

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton