Catalog Number

20325-213

Brand Name

ERBE

Version/Model Number

20325-213

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

41435cdc-250f-4ea8-81fa-1896e1a40cd6

Public Version Date

December 14, 2021

Public Version Number

8

DI Record Publish Date

December 16, 2016

Package DI Number

04050147013346

Quantity per Package

5

Contains DI Package

04050147013339

Package Discontinue Date

December 02, 2021

Package Status

Not in Commercial Distribution

Package Type

Level: 2