Catalog Number

20325-218

Brand Name

ERBEFLO® 2

Version/Model Number

20325-218

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

OCX

Product Code Name

Endoscopic Irrigation/Suction System

Public Device Record Key

4568549c-954d-4133-bb05-212086149235

Public Version Date

December 10, 2021

Public Version Number

1

DI Record Publish Date

December 02, 2021

Package DI Number

04065655000238

Quantity per Package

10

Contains DI Package

04065655000221

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Level 1