Catalog Number

5584180

Brand Name

Introducer Needle

Version/Model Number

5584180

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

K082580,K082580,K082580

Product Code

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

3837ba06-1c22-42cc-b3d8-f3af4943cb09

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 22, 2016

Package DI Number

20801741045138

Quantity per Package

36

Contains DI Package

10801741045131

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX