Artisential Monopolar Spatula

GUDID 08800042700799

Sterile Single-use Surgical Instrument used with electrosurgical generator intended to be used during laparoscopic procedure for manipulation of tissue to cauterize and dissect tissue.

LIVSMED

Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use
Primary Device ID08800042700799
NIH Device Record Key43b07bd2-4cb6-4a5b-b080-a29f20d92577
Commercial Distribution StatusIn Commercial Distribution
Brand NameArtisential Monopolar Spatula
Version Model NumberAMT01S-L
Company DUNS688360116
Company NameLIVSMED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone833-548-7633
Emailinfousa@livsmed.com
Phone833-548-7633
Emailinfousa@livsmed.com
Phone833-548-7633
Emailinfousa@livsmed.com
Phone833-548-7633
Emailinfousa@livsmed.com
Phone833-548-7633
Emailinfousa@livsmed.com
Phone833-548-7633
Emailinfousa@livsmed.com
Phone833-548-7633
Emailinfousa@livsmed.com
Phone833-548-7633
Emailinfousa@livsmed.com
Phone833-548-7633
Emailinfousa@livsmed.com
Phone833-548-7633
Emailinfousa@livsmed.com
Phone833-548-7633
Emailinfousa@livsmed.com
Phone833-548-7633
Emailinfousa@livsmed.com
Phone833-548-7633
Emailinfousa@livsmed.com
Phone833-548-7633
Emailinfousa@livsmed.com
Phone833-548-7633
Emailinfousa@livsmed.com
Phone833-548-7633
Emailinfousa@livsmed.com
Phone833-548-7633
Emailinfousa@livsmed.com
Phone833-548-7633
Emailinfousa@livsmed.com

Device Dimensions

Shaft Length25 Centimeter
Shaft Length25 Centimeter
Shaft Length25 Centimeter
Shaft Length25 Centimeter
Shaft Length25 Centimeter
Shaft Length25 Centimeter
Shaft Length25 Centimeter
Shaft Length25 Centimeter
Shaft Length25 Centimeter
Shaft Length25 Centimeter
Shaft Length25 Centimeter
Shaft Length25 Centimeter
Shaft Length25 Centimeter
Shaft Length25 Centimeter
Shaft Length25 Centimeter
Shaft Length25 Centimeter
Shaft Length25 Centimeter
Shaft Length25 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108800042700799 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-29
Device Publish Date2024-01-20

On-Brand Devices [Artisential Monopolar Spatula]

08800042700805Sterile Single-use Electrosurgical Instrument used for cutting and coagulation during laparoscop
08800042700775Sterile Single-use Electrosurgical Instrument used for cutting and coagulation during laparoscop
08800042700799Sterile Single-use Surgical Instrument used with electrosurgical generator intended to be used d
08800042700782Sterile Single-use Surgical Instrument used with electrosurgical generator intended to be used d

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.