Senhance Ultrasonic 300-11010

GUDID 00815440021566

Senhance Ultrasonic Dissector

TRANSENTERIX, INC.

Soft-tissue ultrasonic robotic surgical instrument, single-use Soft-tissue ultrasonic robotic surgical instrument, single-use Soft-tissue ultrasonic robotic surgical instrument, single-use Soft-tissue ultrasonic robotic surgical instrument, single-use Soft-tissue ultrasonic robotic surgical instrument, single-use Soft-tissue ultrasonic robotic surgical instrument, single-use Soft-tissue ultrasonic robotic surgical instrument, single-use Soft-tissue ultrasonic robotic surgical instrument, single-use Soft-tissue ultrasonic robotic surgical instrument, single-use

• Primary Device ID: 00815440021566
• NIH Device Record Key: d13a3cc4-a254-4442-bbfc-426f190cecd5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Senhance Ultrasonic
• Version Model Number: X9007619
• Catalog Number: 300-11010
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815440021566 [Primary]
GS1	10815440021563 [Package]; Package: Case [10 Units]; In Commercial Distribution

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: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-08-01
• 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