Catalog Number

4500-06

Brand Name

MultiTASC Dissection/Transection Device

Version/Model Number

4500-06

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

K121415

Product Code

DWX

Product Code Name

Stripper, Artery, Intraluminal

Public Device Record Key

a6ad3f0f-75fc-40b7-81f6-2f149fbe90dd

Public Version Date

April 21, 2021

Public Version Number

4

DI Record Publish Date

July 15, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-