Artisential Bipolar Maryland Dissector

GUDID 08800042700430

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 ID: 08800042700430
• NIH Device Record Key: 85bd824b-2324-479c-ba22-9f07c70f14dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Artisential Bipolar Maryland Dissector
• Version Model Number: ABD01S-L
• Company DUNS: 688360116
• Company Name: LIVSMED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 833-548-7633
• Email: infousa@livsmed.com
• Phone: 833-548-7633
• Email: infousa@livsmed.com
• Phone: 833-548-7633
• Email: infousa@livsmed.com
• Phone: 833-548-7633
• Email: infousa@livsmed.com
• Phone: 833-548-7633
• Email: infousa@livsmed.com
• Phone: 833-548-7633
• Email: infousa@livsmed.com
• Phone: 833-548-7633
• Email: infousa@livsmed.com
• Phone: 833-548-7633
• Email: infousa@livsmed.com
• Phone: 833-548-7633
• Email: infousa@livsmed.com
• Phone: 833-548-7633
• Email: infousa@livsmed.com
• Phone: 833-548-7633
• Email: infousa@livsmed.com
• Phone: 833-548-7633
• Email: infousa@livsmed.com
• Phone: 833-548-7633
• Email: infousa@livsmed.com
• Phone: 833-548-7633
• Email: infousa@livsmed.com

Device Dimensions

• Shaft Length: 25 Centimeter
• Shaft Length: 25 Centimeter
• Shaft Length: 25 Centimeter
• Shaft Length: 25 Centimeter
• Shaft Length: 25 Centimeter
• Shaft Length: 25 Centimeter
• Shaft Length: 25 Centimeter
• Shaft Length: 25 Centimeter
• Shaft Length: 25 Centimeter
• Shaft Length: 25 Centimeter
• Shaft Length: 25 Centimeter
• Shaft Length: 25 Centimeter
• Shaft Length: 25 Centimeter
• Shaft Length: 25 Centimeter

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800042700430 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200875

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-30
• Device Publish Date: 2020-07-22

On-Brand Devices [Artisential Bipolar Maryland Dissector]

• 08800042700447: Sterile Single-use Surgical Instrument used with electrosurgical generator intended to be used d
• 08800042700430: Sterile Single-use Surgical Instrument used with electrosurgical generator intended to be used d
• 08800042700089: Sterile Single-use Surgical Instrument used with electrosurgical generator intended to be used d
• 08800042700072: Sterile Single-use Surgical Instrument used with electrosurgical generator intended to be used d
• 08800042701413: Sterile Single-use Surgical Instrument used with electrosurgical generator intended to be used d
• 08800042701444: Sterile Single-use Surgical Instrument used with electrosurgical generator intended to be used d