Catalog Number

RAN-1115N5T

Brand Name

Ranfac Aspiration Needle, 11GA X 150mm, RAN-1115N5T

Version/Model Number

11GA X 150mmN5T

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

K131157,K131157,K131157

Product Code

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

7fabb2c2-5b3b-4233-8790-b4030af0689f

Public Version Date

May 30, 2019

Public Version Number

4

DI Record Publish Date

May 09, 2017

Package DI Number

20858690006352

Quantity per Package

32

Contains DI Package

10858690006355

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case