Catalog Number

KIT-048-00

Brand Name

SSV

Version/Model Number

00884450310434

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

7ae77303-53f9-4474-92e1-d71927376e7a

Public Version Date

November 01, 2021

Public Version Number

7

DI Record Publish Date

May 30, 2017

Package DI Number

10884450310431

Quantity per Package

5

Contains DI Package

00884450310434

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-