Catalog Number

SS-135

Brand Name

SafeSept® Transseptal Guidewire

Version/Model Number

SS-135

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

K081986

Product Code

DRC

Product Code Name

Trocar

Public Device Record Key

b8e54144-c340-4c83-a00d-5de8b9f0b1a8

Public Version Date

August 20, 2020

Public Version Number

4

DI Record Publish Date

November 27, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-