Catalog Number

20325-215

Brand Name

ERBE

Version/Model Number

20325-215

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 02, 2021

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

af83867a-62db-4a4e-9c38-44c8e1905589

Public Version Date

February 14, 2022

Public Version Number

7

DI Record Publish Date

December 16, 2016

Package DI Number

04050147013377

Quantity per Package

10

Contains DI Package

04050147012899

Package Discontinue Date

December 02, 2021

Package Status

Not in Commercial Distribution

Package Type

Level: 1