Catalog Number

E2015

Brand Name

ECOJEKT

Version/Model Number

ECOJEKT

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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"

Yes

For Single-Use

Yes

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

-

Product Code

GAA

Product Code Name

Needle, Aspiration And Injection, Disposable

Public Device Record Key

f4bdcce2-8eff-45d3-96fb-88209453fec8

Public Version Date

October 14, 2021

Public Version Number

2

DI Record Publish Date

February 16, 2021

Package DI Number

48033003342594

Quantity per Package

20

Contains DI Package

08033003342596

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-