Catalog Number

041216800A

Brand Name

STOPCOCKS

Version/Model Number

041216800A

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

c053a6a7-20a4-472a-a057-c8552038a602

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

October 23, 2015

Package DI Number

20886333201420

Quantity per Package

100

Contains DI Package

00886333201426

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box