Catalog Number

117464

Brand Name

S 65-K

Version/Model Number

117464

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

P980023,P980023

Product Code

DRB

Product Code Name

STYLET, CATHETER

Public Device Record Key

a4823a1a-1ed9-4068-8004-970ea9ad63e9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 15, 2014

Package DI Number

04035479004385

Quantity per Package

10

Contains DI Package

04035479145125

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case