Catalog Number

KAL102

Brand Name

ALGINELLE

Version/Model Number

KAL001

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

5e13fb43-9300-40f4-8c56-426b62bd5d25

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 15, 2017

Package DI Number

18016200010151

Quantity per Package

20

Contains DI Package

18016200010441

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton box