Artisential Monopolar Hook - Sterile Single-use Electrosurgical Instrument - LIVSMED

Duns Number:688360116

Device Description: Sterile Single-use Electrosurgical Instrument used for cutting and coagulation during lapa Sterile Single-use Electrosurgical Instrument used for cutting and coagulation during laparoscopic procedure

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More Product Details

Catalog Number

-

Brand Name

Artisential Monopolar Hook

Version/Model Number

AMHL01S-L

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

K200501

Product Code Details

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Device Record Status

Public Device Record Key

ba7ac932-46a4-4413-ace0-fa2f090ee195

Public Version Date

July 03, 2020

Public Version Number

2

DI Record Publish Date

May 22, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LIVSMED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 27