Senhance

GUDID 00815440021856

Senhance® Needle Driver, Articulating (US)

Asensus Surgical, Inc.

Robotic surgical arm system

• Primary Device ID: 00815440021856
• NIH Device Record Key: 9d0eabfb-0080-447d-93f4-104597adfcdc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Senhance
• Version Model Number: X9007675
• Company DUNS: 969118900
• Company Name: Asensus Surgical, Inc.
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815440021856 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211325

FDA Product Code

• NAY: System, Surgical, Computer Controlled Instrument

Sterilization

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

[00815440021856]

Moist Heat or Steam Sterilization

[00815440021856]

Moist Heat or Steam Sterilization

[00815440021856]

Moist Heat or Steam Sterilization

[00815440021856]

Moist Heat or Steam Sterilization

[00815440021856]

Moist Heat or Steam Sterilization

[00815440021856]

Moist Heat or Steam Sterilization

[00815440021856]

Moist Heat or Steam Sterilization

[00815440021856]

Moist Heat or Steam Sterilization

[00815440021856]

Moist Heat or Steam Sterilization

[00815440021856]

Moist Heat or Steam Sterilization

[00815440021856]

Moist Heat or Steam Sterilization

[00815440021856]

Moist Heat or Steam Sterilization

[00815440021856]

Moist Heat or Steam Sterilization

[00815440021856]

Moist Heat or Steam Sterilization

[00815440021856]

Moist Heat or Steam Sterilization

[00815440021856]

Moist Heat or Steam Sterilization

[00815440021856]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-25
• Device Publish Date: 2023-08-17

On-Brand Devices [Senhance]

• 00815440022280: Karl Storz 3D4K 10mm Endoscope Adapter
• 00815440022259: Articulating Instrument Coupler, Needle Driver
• 00815440022242: Articulating Instrument Coupler, Atraumatic Grasper
• 00815440022235: Articulating Instrument Adapter
• 00815440021856: Senhance® Needle Driver, Articulating (US)
• 00815440021825: Senhance® Bipolar Atraumatic Grasper, Articulating (US)
• 00815440021924: Olympus ENDOEYE 3D 10 mm Endoscope Adapter