Catalog Number

002010

Brand Name

CROMATIC 453g

Version/Model Number

002010

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

fae595e3-b532-4f0e-8a68-512582af4d55

Public Version Date

July 01, 2021

Public Version Number

2

DI Record Publish Date

September 06, 2019

Package DI Number

18033712560219

Quantity per Package

24

Contains DI Package

08033712560212

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX