Catalog Number

002003

Brand Name

KROMALGIN Piu 300x18g

Version/Model Number

002003

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 30, 2020

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

Yes

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

-

FDA Premarket Submission

K963609,K963609

Product Code

ELW

Product Code Name

MATERIAL, IMPRESSION

Public Device Record Key

25ff8c8e-e8ef-4b1c-b507-304069dd1b9e

Public Version Date

July 31, 2020

Public Version Number

2

DI Record Publish Date

July 31, 2019

Package DI Number

00803371256263

Quantity per Package

300

Contains DI Package

00803371256102

Package Discontinue Date

July 30, 2020

Package Status

Not in Commercial Distribution

Package Type

BOX