Catalog Number

Not Applicable

Brand Name

Smith's Catheters

Version/Model Number

SM-84318

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

-

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

-

FDA Premarket Submission

-

Product Code

FOZ

Product Code Name

Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Public Device Record Key

472ac374-4dbc-4fa9-ba03-47b04a568069

Public Version Date

August 23, 2021

Public Version Number

1

DI Record Publish Date

August 13, 2021

Package DI Number

00840155411159

Quantity per Package

50

Contains DI Package

00840155411142

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box