Catalog Number

10237425

Brand Name

SmartSite

Version/Model Number

10237425

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

-

Product Code

FMG

Product Code Name

Stopcock, i.V. Set

Public Device Record Key

1acd1a9a-2223-4307-8651-e1004a4975fc

Public Version Date

July 13, 2021

Public Version Number

5

DI Record Publish Date

September 22, 2016

Package DI Number

50885403234161

Quantity per Package

2

Contains DI Package

20885403234160

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box