Catalog Number

-

Brand Name

IMPROVACUTER® Multi Sample Needle

Version/Model Number

21G × 1 1/2″

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

K153388,K153388,K153388

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

894df044-8730-49b1-8886-1e39c6482940

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

December 26, 2016

Package DI Number

46933395621210

Quantity per Package

40

Contains DI Package

16933395621219

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-