Catalog Number

101-0710

Brand Name

EsCom 100 C2 Syringe

Version/Model Number

101-0710

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K110428,K110428,K110428

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Public Device Record Key

f86e8483-b668-47dc-ac3c-ff5e9cd971a0

Public Version Date

July 01, 2019

Public Version Number

3

DI Record Publish Date

August 21, 2018

Package DI Number

00210205180029

Quantity per Package

20

Contains DI Package

08809262955293

Package Discontinue Date

June 30, 2019

Package Status

Not in Commercial Distribution

Package Type

-