Catalog Number

SS-135

Brand Name

SafeSept Transseptal Guidwire

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

K170671,K170671

Product Code

DRC

Product Code Name

Trocar

Public Device Record Key

04aaf13f-d6c8-4581-aa52-2c2645b1cf90

Public Version Date

August 20, 2020

Public Version Number

3

DI Record Publish Date

March 02, 2018

Package DI Number

30858769006105

Quantity per Package

5

Contains DI Package

00858769006104

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box