Catalog Number

38-00010

Brand Name

Enthus

Version/Model Number

38-00010

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

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

K041028,K041028,K041028

Product Code

ELW

Product Code Name

Material, Impression

Public Device Record Key

230aa96e-6ff4-42c1-8505-ac148c6e073c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 07, 2016

Package DI Number

10353045001868

Quantity per Package

12

Contains DI Package

00353045001861

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case