Catalog Number

-

Brand Name

Single Use Aspiration Needle NA-U200H

Version/Model Number

NA-U200H-8025

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 21, 2022

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

b2a069ed-846a-46ba-91ed-b2b6b2df0dc9

Public Version Date

February 22, 2022

Public Version Number

2

DI Record Publish Date

June 14, 2018

Package DI Number

14953170402521

Quantity per Package

1

Contains DI Package

04953170402524

Package Discontinue Date

February 21, 2022

Package Status

Not in Commercial Distribution

Package Type

-