Catalog Number

-

Brand Name

VALVULOTOME (DETACHABLE TYPE)

Version/Model Number

C-0103B

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

-

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

K895878,K895878

Product Code

DWX

Product Code Name

STRIPPER, ARTERY, INTRALUMINAL

Public Device Record Key

6488d7c4-5faf-4774-a925-aaf4fe9ec3fc

Public Version Date

October 08, 2018

Public Version Number

5

DI Record Publish Date

September 21, 2016

Package DI Number

14953170047678

Quantity per Package

1

Contains DI Package

04953170047671

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-