Catalog Number

20150-236

Brand Name

ERBE

Version/Model Number

20150-236

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

K072404,K083608,K072404,K083608

Product Code

FQH

Product Code Name

LAVAGE, JET

Public Device Record Key

f4b66178-2a32-475f-9936-b87f0ce87d73

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 16, 2016

Package DI Number

04050147019263

Quantity per Package

4

Contains DI Package

04050147019256

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Level: 1