Catalog Number

AM0845SL3-1

Brand Name

Preloaded in PSS1820SL3 Round Hub Needles, Single Pack

Version/Model Number

PSS1820SL3 Round Hub Needles, Single Pack

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"

-

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

IWJ

Product Code Name

System, Applicator, Radionuclide, Manual

Public Device Record Key

d433ad57-5ba9-40d0-932a-6bc9baa4123c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 27, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-