Catalog Number

101-0703

Brand Name

EsCom100 A3 Syringe

Version/Model Number

101-0703

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

64f080b7-7122-4ae0-b584-893963a21190

Public Version Date

January 26, 2021

Public Version Number

7

DI Record Publish Date

February 20, 2017

Package DI Number

00202201110070

Quantity per Package

280

Contains DI Package

08809262955231

Package Discontinue Date

January 25, 2021

Package Status

Not in Commercial Distribution

Package Type

-