Senhance Ultrasonic 300-01010

GUDID 00815440021580

Senhance Ultrasonic Generator

TRANSENTERIX, INC.

Electrosurgical/ultrasonic surgical system generator

• Primary Device ID: 00815440021580
• NIH Device Record Key: 9b1d9364-1024-48e9-9a07-9eedac8ec4c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Senhance Ultrasonic
• Version Model Number: X9007621
• Catalog Number: 300-01010
• Company DUNS: 969118900
• Company Name: TRANSENTERIX, 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	00815440021580 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182421

FDA Product Code

• NAY: System, Surgical, Computer Controlled Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-07
• Device Publish Date: 2019-02-04

On-Brand Devices [Senhance Ultrasonic]

• 00815440021597: Senhance Ultrasonic Footswitch
• 00815440021580: Senhance Ultrasonic Generator
• 00815440021573: Senhance Ultrasonic Transducer
• 00815440021566: Senhance Ultrasonic Dissector
• 00815440021122: Adapter, Senhance Ultrasonic