Catalog Number

-

Brand Name

ClassOne

Version/Model Number

103-35

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 25, 2019

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K940120

Product Code

ELW

Product Code Name

MATERIAL, IMPRESSION

Public Device Record Key

12ffa83c-76a1-47dd-8be1-89e3b6b9d365

Public Version Date

January 01, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-