Catalog Number

119291

Brand Name

S 60-S

Version/Model Number

119291

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

K191469,P820076,K191469,P820076

Product Code

DRB

Product Code Name

STYLET, CATHETER

Public Device Record Key

fb1f90a3-8e5f-47c8-8093-335129450c9f

Public Version Date

August 09, 2019

Public Version Number

4

DI Record Publish Date

August 15, 2014

Package DI Number

04035479005788

Quantity per Package

10

Contains DI Package

04035479145088

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case