Catalog Number

20325-203

Brand Name

ERBE

Version/Model Number

20325-203

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

K103696,K103696,K103696

Product Code

OCX

Product Code Name

Endoscopic Irrigation/Suction System

Public Device Record Key

42f84a0c-5bc4-48ea-a229-6c9055174184

Public Version Date

August 30, 2021

Public Version Number

1

DI Record Publish Date

August 20, 2021

Package DI Number

04050147022645

Quantity per Package

7

Contains DI Package

04050147022607

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Level 1