Catalog Number

103-0602-175

Brand Name

SilverSpeed

Version/Model Number

103-0602-175

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

K993257

Product Code

DQX

Product Code Name

WIRE, GUIDE, CATHETER

Public Device Record Key

bf919474-052f-4c3a-b4a9-7f3b0ebcc0e3

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 06, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-