Catalog Number

DUAN-8.3-18-25.0-8S-PIG

Brand Name

Cook

Version/Model Number

G56892

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

LJE

Product Code Name

CATHETER, NEPHROSTOMY

Public Device Record Key

16a40ec3-6918-4fc7-8c8a-eacebd9a9b9e

Public Version Date

June 07, 2022

Public Version Number

4

DI Record Publish Date

October 02, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-