Catalog Number

STCVC110

Brand Name

MEDLINE INDUSTRIES, INC.

Version/Model Number

STCVC110

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

f31ef92d-3eeb-48e7-b9d4-7b4be4600663

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

February 03, 2020

Package DI Number

00653160341256

Quantity per Package

5

Contains DI Package

10653160341253

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE