Catalog Number

STCVC01145B

Brand Name

MEDLINE

Version/Model Number

STCVC01145B

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

Yes

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

-

FDA Premarket Submission

-

Product Code

OFD

Product Code Name

Catheter introducer kit

Public Device Record Key

52e70a41-b55d-4f3a-919e-2af5ee70a0e8

Public Version Date

April 12, 2022

Public Version Number

1

DI Record Publish Date

April 04, 2022

Package DI Number

00653160351927

Quantity per Package

5

Contains DI Package

10653160351924

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE