Catalog Number

4065-

Brand Name

Thermo Clone VPS

Version/Model Number

4065-

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K083701

Product Code

ELW

Product Code Name

MATERIAL, IMPRESSION

Public Device Record Key

45a0090b-764c-49db-af12-c47b7e72272f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 04, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-