Artisential Monopolar Spatula

GUDID 08800042703332

This product is sterile, single-use, invasive instrument that used in laparoscopic surgery. There are two version, one for Hook and Spatula. The two models are same except for end-tip.

LIVSMED

Endoscopic electrosurgical electrode, monopolar, single-use

• Primary Device ID: 08800042703332
• NIH Device Record Key: 818edb46-205d-4921-8e9d-e7d2727d2c2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Artisential Monopolar Spatula
• Version Model Number: 5AMT01-LH
• 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: 8335487633
• Email: infousa@livsmed.com
• Phone: 8335487633
• Email: infousa@livsmed.com
• Phone: 8335487633
• Email: infousa@livsmed.com
• Phone: 8335487633
• Email: infousa@livsmed.com
• Phone: 8335487633
• Email: infousa@livsmed.com
• Phone: 8335487633
• Email: infousa@livsmed.com
• Phone: 8335487633
• Email: infousa@livsmed.com
• Phone: 8335487633
• Email: infousa@livsmed.com
• Phone: 8335487633
• Email: infousa@livsmed.com
• Phone: 8335487633
• Email: infousa@livsmed.com
• Phone: 8335487633
• Email: infousa@livsmed.com
• Phone: 8335487633
• Email: infousa@livsmed.com
• Phone: 8335487633
• Email: infousa@livsmed.com
• Phone: 8335487633
• Email: infousa@livsmed.com
• Phone: 8335487633
• Email: infousa@livsmed.com
• Phone: 8335487633
• Email: infousa@livsmed.com
• Phone: 8335487633
• Email: infousa@livsmed.com

Device Dimensions

• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800042703332 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240657

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: 2024-08-01
• Device Publish Date: 2024-07-24

On-Brand Devices [Artisential Monopolar Spatula]

• 08800042700805: Sterile Single-use Electrosurgical Instrument used for cutting and coagulation during laparoscop
• 08800042700775: Sterile Single-use Electrosurgical Instrument used for cutting and coagulation during laparoscop
• 08800042700799: Sterile Single-use Surgical Instrument used with electrosurgical generator intended to be used d
• 08800042700782: Sterile Single-use Surgical Instrument used with electrosurgical generator intended to be used d
• 08800042703349: This product is sterile, single-use, invasive instrument that used in laparoscopic surgery. Ther
• 08800042703332: This product is sterile, single-use, invasive instrument that used in laparoscopic surgery. Ther