Catalog Number

-

Brand Name

Single Use Aspiration Needle

Version/Model Number

NA-U401SX-4025N

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

K180668,K190239,K180668,K190239

Product Code

FCG

Product Code Name

Biopsy Needle

Public Device Record Key

8d2e6556-72df-48d1-a846-0aadf679194a

Public Version Date

September 05, 2022

Public Version Number

4

DI Record Publish Date

February 10, 2020

Package DI Number

14953170402002

Quantity per Package

5

Contains DI Package

04953170402005

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-