Catalog Number

20325-217

Brand Name

ERBE

Version/Model Number

20325-217

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 10, 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

K143186,K143186,K143186

Product Code

OCX

Product Code Name

endoscopic irrigation/suction system

Public Device Record Key

ae2e88d9-e15b-4ae4-a2e0-498cb67af6ee

Public Version Date

October 25, 2022

Public Version Number

6

DI Record Publish Date

December 15, 2016

Package DI Number

04050147013827

Quantity per Package

5

Contains DI Package

04050147013810

Package Discontinue Date

November 10, 2021

Package Status

Not in Commercial Distribution

Package Type

Level: 2