Catalog Number

-

Brand Name

SINGLE USE ASPIRATION NEEDLE

Version/Model Number

NA-200H-8022

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 23, 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

K023272,K023272

Product Code

FCG

Product Code Name

Biopsy needle

Public Device Record Key

74977101-fbb7-4771-b75f-31857fabdc1e

Public Version Date

June 24, 2022

Public Version Number

4

DI Record Publish Date

September 21, 2016

Package DI Number

14953170169967

Quantity per Package

1

Contains DI Package

04953170169960

Package Discontinue Date

June 23, 2022

Package Status

Not in Commercial Distribution

Package Type

-