Artisential Bipolar Forceps

GUDID 08800042700027

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

LIVSMED

Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use
Primary Device ID08800042700027
NIH Device Record Key27a8070a-ac0b-4cc9-9fdf-b78bef4efb28
Commercial Distribution StatusIn Commercial Distribution
Brand NameArtisential Bipolar Forceps
Version Model NumberABF01-F
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 Batchfalse
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

Device Dimensions

Shaft Length38 Centimeter
Shaft Length38 Centimeter
Shaft Length38 Centimeter
Shaft Length38 Centimeter
Shaft Length38 Centimeter
Shaft Length38 Centimeter
Shaft Length38 Centimeter
Shaft Length38 Centimeter
Shaft Length38 Centimeter
Shaft Length38 Centimeter
Shaft Length38 Centimeter
Shaft Length38 Centimeter
Shaft Length38 Centimeter
Shaft Length38 Centimeter

Operating and Storage Conditions

Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108800042700027 [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 Date2020-07-10
Device Publish Date2020-07-02

Devices Manufactured by LIVSMED

08800042702793 - ArtiSential Precise Dissector, 5mm2024-03-05 Sterile Single-use Manual Surgical Instrument for general use.
08800042700133 - Artisential Maryland Dissector2024-01-30 Sterile Single-use Manual Surgical Instrument for general use
08800042700294 - Artisential Maryland Dissector2024-01-30 Sterile Single-use Manual Surgical Instrument for general use
08800042700638 - Artisential Monopolar Hook2024-01-30 Sterile Single-use Surgical Instrument used with electrosurgical generator intended to be used during laparoscopic procedure for
08800042701055 - Artisential Maryland Dissector2024-01-30 Sterile Single-use Manual Surgical Instrument for general use
08800042701079 - Artisential Maryland Dissector2024-01-30 Sterile Single-use Manual Surgical Instrument for general use
08800042701352 - Artisential Clip Applier2024-01-30 Sterile Single-use surgical ligation clip applier
08800042701383 - Artisential Clip Applier2024-01-30 Sterile Single-use surgical ligation clip applier

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