Catalog Number

SMCE-60.1.0

Brand Name

Summit International

Version/Model Number

SMCE-60.1.0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

April 30, 2024

Issuing Agency

In HIBCC

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)

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

ef5cd9d1-ae48-4bf4-a066-6c68b3ef6426

Public Version Date

May 11, 2021

Public Version Number

1

DI Record Publish Date

May 03, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-