Catalog Number

0012

Brand Name

EZ Clean

Version/Model Number

0012

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

-

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

d9d19660-630e-47aa-8a51-113d85fa02c0

Public Version Date

June 11, 2021

Public Version Number

11

DI Record Publish Date

December 01, 2016

Package DI Number

50614559100088

Quantity per Package

264

Contains DI Package

10614559100080

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE