Catalog Number

-

Brand Name

SpiderFX™

Version/Model Number

SPD2-US-050-190

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

K111010

Product Code

NTE

Product Code Name

Temporary Carotid Catheter for Embolic Capture

Public Device Record Key

b3f0b8c0-fcb0-4fc1-bf11-746992d5017f

Public Version Date

April 09, 2019

Public Version Number

4

DI Record Publish Date

July 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-