Catalog Number

VADC

Brand Name

Statlock Arterial

Version/Model Number

VADC

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"

Yes

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

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

37da6706-1771-44d2-93e0-f42a79a1e405

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 15, 2016

Package DI Number

20801741083048

Quantity per Package

10

Contains DI Package

10801741083041

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX