Catalog Number

RT-10000-03N

Brand Name

ELEOS™

Version/Model Number

RT-10000-03N

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K161520

Product Code

HWT

Product Code Name

TEMPLATE

Public Device Record Key

8029d6d9-06d6-4eea-b9a5-61ba42a72a09

Public Version Date

October 08, 2018

Public Version Number

1

DI Record Publish Date

September 06, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-