Catalog Number

-

Brand Name

Single Use Aspiration Needle NA-U200H

Version/Model Number

NA-U200H-8022S

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

K180449,K180449

Product Code

FCG

Product Code Name

Biopsy needle

Public Device Record Key

a49c7e6b-b7cf-4b7c-9467-435823998188

Public Version Date

September 05, 2022

Public Version Number

3

DI Record Publish Date

July 02, 2018

Package DI Number

14953170380522

Quantity per Package

5

Contains DI Package

04953170380525

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-