Catalog Number

-

Brand Name

ELASTY Micro Cannula

Version/Model Number

ELASTY Micro Cannula 25Gx50mm

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K092831,K092831,K092831,K092831

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

4a5a7350-da33-40e1-9b24-78e9134a165a

Public Version Date

October 23, 2019

Public Version Number

3

DI Record Publish Date

July 10, 2019

Package DI Number

38809407784628

Quantity per Package

2500

Contains DI Package

28809407784621

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-