Catalog Number

20325-248

Brand Name

ERBE

Version/Model Number

20325-248

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

-

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

K162152,K162152,K162152

Product Code

OCX

Product Code Name

Endoscopic Irrigation/Suction System

Public Device Record Key

9f37fae5-6d87-4cfa-9b60-a609e1c77af4

Public Version Date

August 30, 2021

Public Version Number

1

DI Record Publish Date

August 22, 2021

Package DI Number

04050147022683

Quantity per Package

10

Contains DI Package

04050147022614

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Level 1