Catalog Number

3685

Brand Name

Dover

Version/Model Number

3685

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GBX

Product Code Name

CATHETER, IRRIGATION

Public Device Record Key

e8412bd6-4c2a-4f25-8a90-7ea8038f4810

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

June 30, 2018

Package DI Number

20884521008059

Quantity per Package

20

Contains DI Package

10884521008052

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE