Catalog Number

IN 20100N

Brand Name

INTRODUCER NEEDLE

Version/Model Number

INTRODUCER NEEDLE

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

f970b48d-d6c4-4a98-98a0-a3d1c8955abe

Public Version Date

October 10, 2022

Public Version Number

2

DI Record Publish Date

March 01, 2021

Package DI Number

48058983741793

Quantity per Package

20

Contains DI Package

08058983741795

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-