Catalog Number

20325-216

Brand Name

ERBE

Version/Model Number

20325-216

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 23, 2017

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

K103235,K103235,K103235

Product Code

OCX

Product Code Name

endoscopic irrigation/suction system

Public Device Record Key

7bd195e4-08c8-41ca-8598-c1310ae44e53

Public Version Date

April 23, 2019

Public Version Number

5

DI Record Publish Date

December 16, 2016

Package DI Number

04050147013391

Quantity per Package

10

Contains DI Package

04050147012905

Package Discontinue Date

May 23, 2017

Package Status

Not in Commercial Distribution

Package Type

Level: 1