Catalog Number

KOR302

Brand Name

ALGINOR

Version/Model Number

KOR001

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

-

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

ELW

Product Code Name

Material, Impression

Public Device Record Key

e8317107-df92-4dfe-913a-74ebd39a650a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 15, 2017

Package DI Number

18016200010144

Quantity per Package

20

Contains DI Package

18016200010113

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

cartoon box