Catalog Number

N10122300

Brand Name

Fine Needle Aspiration

Version/Model Number

N10122300

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

-

Product Code

GAA

Product Code Name

Needle, Aspiration And Injection, Disposable

Public Device Record Key

8f9831aa-2a22-4801-bc93-c21c57cbcb6f

Public Version Date

August 13, 2019

Public Version Number

1

DI Record Publish Date

August 05, 2019

Package DI Number

05711055000208

Quantity per Package

20

Contains DI Package

15711055000205

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Retail Box