Catalog Number

38-00011

Brand Name

Enthus

Version/Model Number

38-00011

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

Yes

Prescription Use (Rx)

-

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

d9d968e5-0133-4215-9362-11360a66cd5f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 07, 2016

Package DI Number

10353045001875

Quantity per Package

12

Contains DI Package

00353045001878

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case