Catalog Number

ESI1151

Brand Name

A.M.I. EasyShear Mini Disposable Tips Premium

Version/Model Number

ESI1151

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

13db7503-bc7b-4f8e-8f90-76f2274303ca

Public Version Date

April 15, 2019

Public Version Number

1

DI Record Publish Date

April 05, 2019

Package DI Number

EAMIESI11511

Quantity per Package

10

Contains DI Package

EAMIESI11510

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-