ArtiSential Monopolar Hook

GUDID 08800042700539

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. This product is a specific component, but not the entire electrosurgical device. The device is not intended to be marketed with multiple components, accessories, and as part of a system.

LIVSMED

Endoscopic electrosurgical electrode, monopolar, single-use

• Primary Device ID: 08800042700539
• NIH Device Record Key: ce58650b-65fd-4e6c-89cf-38f4117927d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ArtiSential Monopolar Hook
• Version Model Number: AMHD01-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: false
• OTC Over-The-Counter: false

Device Dimensions

• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800042700539 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230498

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: 2024-07-02
• Device Publish Date: 2024-06-24

On-Brand Devices [ArtiSential Monopolar Hook]

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• 08800042700737: Sterile Single-use Electrosurgical Instrument used for cutting and coagulation during laparoscop
• 08800042700713: Sterile Single-use Electrosurgical Instrument used for cutting and coagulation during laparoscop
• 08800042700553: Sterile Single-use Electrosurgical Instrument used for cutting and coagulation during laparoscop
• 08800042700546: Sterile Single-use Electrosurgical Instrument used for cutting and coagulation during laparoscop
• 08800042700720: Sterile Single-use Electrosurgical Instrument used for cutting and coagulation during laparoscop
• 08800042700645: Sterile Single-use Electrosurgical Instrument used for cutting and coagulation during laparoscop
• 08800042700676: Sterile Single-use Surgical Instrument used with electrosurgical generator intended to be used d
• 08800042700669: Sterile Single-use Surgical Instrument used with electrosurgical generator intended to be used d
• 08800042700621: Sterile Single-use Surgical Instrument used with electrosurgical generator intended to be used d
• 08800042700638: Sterile Single-use Surgical Instrument used with electrosurgical generator intended to be used d
• 08800042700539: This product is sterile, single-use, invasive instrument that used in laparoscopic surgery. Ther
• 08800042703738: This product is sterile, single-use, invasive instrument that used in laparoscopic surgery. Ther
• 08800042703721: This product is sterile, single-use, invasive instrument that used in laparoscopic surgery. Ther