Catalog Number

70105.4606

Brand Name

NA

Version/Model Number

PIK Dilator small

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

K131666,K131666

Product Code

DWF

Product Code Name

CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Public Device Record Key

0fc0841e-db9d-4de3-8271-1e44eca71de7

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 03, 2016

Package DI Number

04037691746227

Quantity per Package

5

Contains DI Package

04037691746500

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-