Catalog Number

-

Brand Name

Irrigation tube

Version/Model Number

Irrigation tube

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

-

Product Code

EBW

Product Code Name

CONTROLLER, FOOT, HANDPIECE AND CORD

Public Device Record Key

4c55a2dc-c299-489f-ad5a-1bac2e07bf13

Public Version Date

April 23, 2019

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

34560264562029

Quantity per Package

10

Contains DI Package

04560264562028

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-