Catalog Number

101-0804

Brand Name

EsFlow A3.5 Syringe

Version/Model Number

101-0804

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

-

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Public Device Record Key

826c8d17-e332-402a-aa44-d72527b1e79f

Public Version Date

January 26, 2021

Public Version Number

7

DI Record Publish Date

February 20, 2017

Package DI Number

20191201160045

Quantity per Package

30

Contains DI Package

08809262954746

Package Discontinue Date

August 31, 2019

Package Status

Not in Commercial Distribution

Package Type

-