Catalog Number

ESI1131

Brand Name

A.M.I. EasyShear Disposable Tips Premium

Version/Model Number

ESI1131

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K182013,K182013

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

ccf08e82-35dc-462e-acbe-0f395e85f70d

Public Version Date

April 15, 2019

Public Version Number

1

DI Record Publish Date

April 05, 2019

Package DI Number

EAMIESI11311

Quantity per Package

10

Contains DI Package

EAMIESI11310

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-