Catalog Number

-

Brand Name

ELASTY Mesoneedle 34Gx8mm

Version/Model Number

FDN 57

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)

Yes

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

be213e87-2b21-42d5-b0da-5b3c65daf71d

Public Version Date

November 13, 2019

Public Version Number

1

DI Record Publish Date

November 05, 2019

Package DI Number

38809407786578

Quantity per Package

5000

Contains DI Package

28809407786571

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-