Catalog Number

SANT-18-20-PLV

Brand Name

Cook

Version/Model Number

G26648

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K182709

Product Code

KOB

Product Code Name

CATHETER, SUPRAPUBIC (AND ACCESSORIES)

Public Device Record Key

936dee4d-5d77-4d95-b52d-677cd30ddf58

Public Version Date

May 20, 2020

Public Version Number

1

DI Record Publish Date

May 12, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-