Catalog Number

4079

Brand Name

Thermo Clone

Version/Model Number

4079

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

K081120

Product Code

ELW

Product Code Name

MATERIAL, IMPRESSION

Public Device Record Key

17633082-5b07-44d2-844f-e7d63cf75000

Public Version Date

March 22, 2021

Public Version Number

1

DI Record Publish Date

March 13, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-