Catalog Number

101-0705

Brand Name

EsCom100 A4 Syringe

Version/Model Number

101-0705

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)

-

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

426d1d93-61d3-4f84-b214-a044c01fb8d5

Public Version Date

June 28, 2022

Public Version Number

3

DI Record Publish Date

August 23, 2018

Package DI Number

00210205180012

Quantity per Package

10

Contains DI Package

08809262955200

Package Discontinue Date

January 25, 2021

Package Status

Not in Commercial Distribution

Package Type

-