Catalog Number

SS-140

Brand Name

SafeSept Transseptal Guidewire

Version/Model Number

SS-140

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

K221707,K221707

Product Code

DRC

Product Code Name

Trocar

Public Device Record Key

14d4db73-8b3d-4237-8e23-33609347e53b

Public Version Date

October 04, 2022

Public Version Number

1

DI Record Publish Date

September 26, 2022

Package DI Number

30858769006419

Quantity per Package

5

Contains DI Package

00858769006418

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box