Senhance Ultrasonic 300-01012

GUDID 00815440021597

Senhance Ultrasonic Footswitch

TRANSENTERIX, INC.

Foot-switch, pneumatic

• Primary Device ID: 00815440021597
• NIH Device Record Key: c7a58997-5dee-4ab0-af0d-6ccf9baf2792
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Senhance Ultrasonic
• Version Model Number: X9007641
• Catalog Number: 300-01012
• 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: true
• Serial Number: false
• 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	00815440021597 [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