Catalog Number

-

Brand Name

SAFTI-JECT SV

Version/Model Number

BC 9504

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)

-

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

1f4b9088-2a8a-4f38-8fc7-cdebd56ff708

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

April 30, 2017

Package DI Number

00813153024652

Quantity per Package

1

Contains DI Package

10813153024659

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-