Catalog Number

101-0903

Brand Name

EsFlow LV A3 Syringe

Version/Model Number

101-0903

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 25, 2021

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K120768,K120768

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Public Device Record Key

a5c7c8e1-bf22-47c7-bf34-a13d0f6a57cf

Public Version Date

January 26, 2021

Public Version Number

2

DI Record Publish Date

August 23, 2018

Package DI Number

20200723170026

Quantity per Package

15

Contains DI Package

08809262954647

Package Discontinue Date

January 25, 2021

Package Status

Not in Commercial Distribution

Package Type

-