Catalog Number

ES0201

Brand Name

AEM enTouch 2X Scissor

Version/Model Number

ES0201

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"

Yes

For Single-Use

-

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

K201018,K201018

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

48d4289f-ddac-4c3d-84f1-446a2a5e9124

Public Version Date

July 29, 2020

Public Version Number

1

DI Record Publish Date

July 21, 2020

Package DI Number

20815288013994

Quantity per Package

10

Contains DI Package

10815288013997

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-