Catalog Number

041216000A

Brand Name

Stopcock

Version/Model Number

041216000A

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

K770383,K770383

Product Code

KOC

Product Code Name

Accessories, Blood Circuit, Hemodialysis

Public Device Record Key

33915805-f3ff-422c-b6ab-785c6f97a000

Public Version Date

July 20, 2018

Public Version Number

1

DI Record Publish Date

June 19, 2018

Package DI Number

20886333201413

Quantity per Package

25

Contains DI Package

00886333201419

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box