Catalog Number

10082

Brand Name

Dover

Version/Model Number

10082

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

JOL

Product Code Name

CATHETER AND TIP, SUCTION

Public Device Record Key

0e30bfb0-46c6-4b82-a467-cee6557c7d8f

Public Version Date

February 15, 2019

Public Version Number

5

DI Record Publish Date

May 25, 2017

Package DI Number

20884521083186

Quantity per Package

25

Contains DI Package

10884521083189

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE