Catalog Number

101-0708

Brand Name

EsCom100 B2 Syringe

Version/Model Number

101-0708

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,K110428

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Public Device Record Key

48850867-5a17-4536-988c-88b6e8159833

Public Version Date

January 26, 2021

Public Version Number

8

DI Record Publish Date

February 20, 2017

Package DI Number

20200323170020

Quantity per Package

20

Contains DI Package

08809262955279

Package Discontinue Date

May 31, 2019

Package Status

Not in Commercial Distribution

Package Type

-