Catalog Number

-

Brand Name

VALULINE

Version/Model Number

5125-482

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)

Yes

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

-

Product Code

ELW

Product Code Name

Material, Impression

Public Device Record Key

84f8c92b-c048-44fe-9880-556c588ccde2

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 18, 2017

Package DI Number

00366975010056

Quantity per Package

8

Contains DI Package

00366975007926

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE