Catalog Number

384061

Brand Name

Splittable Needle Introducer

Version/Model Number

28 GA (1.2F) x 20 mm

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

K920755,K920755

Product Code

LJS

Product Code Name

Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days

Public Device Record Key

5453c4e0-ca4d-457b-b900-97481abe34e1

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 23, 2015

Package DI Number

20886333209594

Quantity per Package

10

Contains DI Package

00886333209590

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box