Catalog Number

0600-3140-000

Brand Name

Electro Lavage

Version/Model Number

0600-3140-000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 24, 2019

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"

Yes

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

K955352,K955352

Product Code

GEI

Product Code Name

Electrosurgical, cutting & coagulation & accessories

Public Device Record Key

d7a7fb83-7578-485f-8d3e-3dfa8b3d7d95

Public Version Date

February 25, 2019

Public Version Number

1

DI Record Publish Date

January 24, 2019

Package DI Number

10817984010560

Quantity per Package

10

Contains DI Package

00817984010563

Package Discontinue Date

January 24, 2019

Package Status

Not in Commercial Distribution

Package Type

Inner pack