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

AMHR01-F

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K200501

Product Code Details

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Device Record Status

Public Device Record Key

6b818a14-8023-455e-b9ca-ee5bacf9926a

Public Version Date

November 23, 2020

Public Version Number

1

DI Record Publish Date

November 15, 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