Catalog Number

-

Brand Name

Single Use Aspiration Needle NA-U201H

Version/Model Number

NA-U201H-8025

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"

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

K181994,K181994

Product Code

FCG

Product Code Name

Biopsy needle

Public Device Record Key

1a924b60-839f-4a51-8729-ec0abcb9123b

Public Version Date

December 17, 2021

Public Version Number

4

DI Record Publish Date

November 06, 2018

Package DI Number

14953170402620

Quantity per Package

5

Contains DI Package

04953170402623

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-