SonaStar

GUDID 00841626101616

SonaStar FS 1000 RF Ultrasonic Surgical Aspiration System (Compatible for 110/220 or 230 V)

MISONIX, INC.

Ultrasonic surgical system generator

• Primary Device ID: 00841626101616
• NIH Device Record Key: 9b2fc27d-0ea8-4dbb-9cb3-f99dcf39a84b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SonaStar
• Version Model Number: SYSTEM-M260-1 (Rev L or higher)
• Company DUNS: 065963449
• Company Name: MISONIX, 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: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841626101616 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062471

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-09-24
• Device Publish Date: 2016-09-24

On-Brand Devices [SonaStar]

• 20841626100576: SonaStar Single-Use Monopolar Handpiece Cable
• 10841626100531: SonaStar Tubeset
• 10841626100524: SonaStar Tubeset Used With FHF-XXXXX Serial Number Console
• 00841626100534: SonaStar Tubeset
• 00841626100527: SonaStar Tubeset Used With FHF-XXXXX Serial Number Console
• 00841626100572: SonaStar Single-Use Monopolar Handpiece Cable
• 00841626100510: SonaStar Long Curved Micro OsteoSculpt® Procedure Pack
• 00841626100503: SonaStar Standard Short OsteoSculpt® Procedure Pack
• 00841626100480: SonaStar 2.6mm Macro Procedure Pack
• 00841626100473: SonaStar 1.9mm Standard Deep Access Probe
• 00841626100466: SonaStar 1.9mm Standard Notched Procedure Pack
• 00841626100459: SonaStar 1.9mm Standard Long Curved Procedure Pack
• 00841626100442: SonaStar 1.6mm Micro Long Curved Procedure Pack
• 00841626100435: SonaStar 1.1mm Precision Long Curved Procedure Pack
• 00841626100398: SonaStar 1.9mm Standard Long Curved+ Procedure Pack
• 00841626100381: SonaStar 1.1mm Precision Procedure Pack
• 00841626100374: SonaStar 1.6 mm Micro Procedure Pack
• 00841626100367: SonaStar 2.6mm Macro Procedure Pack
• 00841626100350: SonaStar 1.9mm Standard Procedure Pack
• 00841626101869: SonaStar FS 1000 RF Ultrasonic Surgical Aspiration System (240V)
• 00841626101852: SonaStar FS 1000 RF Ultrasonic Surgical Aspiration System (240 V)
• 00841626101845: SonaStar FS 1000 RF Ultrasonic Surgical Aspiration System (240 V)
• 00841626101838: SonaStar FS 1000 RF Ultrasonic Surgical Aspiration System (240V)
• 00841626101821: SonaStar FS 1000 RF Ultrasonic Surgical Aspiration System (Compatible for 110/220 or 230 V)
• 00841626101814: SonaStar FS 1000 RF Ultrasonic Surgical Aspiration System (Compatible for 110/220 or 230 V)
• 00841626101807: SonaStar FS 1000 RF Ultrasonic Surgical Aspiration System (Compatible for 110/220 or 230 V)
• 00841626101791: SonaStar FS 1000 RF Ultrasonic Surgical Aspiration System (Compatible for 110/220 or 230 V)
• 00841626101784: SonaStar FS 1000 RF Ultrasonic Surgical Aspiration System (Compatible for 100/200 V)
• 00841626101777: SonaStar FS 1000 RF Ultrasonic Surgical Aspiration System (Compatible for 100/200 V)
• 00841626101760: SonaStar FS 1000 RF Ultrasonic Surgical Aspiration System (Compatible for 100/200V)
• 00841626101753: SonaStar FS 1000 RF Ultrasonic Surgical Aspiration System (Compatible for 100/200 V)
• 00841626101746: SonaStar FS 1000 RF Ultrasonic Surgical Aspiration System (240 V)
• 00841626101722: SonaStar FS 1000 RF Ultrasonic Surgical Aspiration System (240 V)
• 00841626101708: SonaStar FS 1000 RF Ultrasonic Surgical Aspiration System (240 V)
• 00841626101685: SonaStar FS 1000 RF Ultrasonic Surgical Aspiration System (240 V)
• 00841626101661: SonaStar FS 1000 RF Ultrasonic Surgical Aspiration System (Compatible for 110/220 or 230V)
• 00841626101654: SonaStar FS 1000 RF Ultrasonic Surgical Aspiration System (Compatible for 110/220 or 230 V)
• 00841626101647: SonaStar FS 1000 RF Ultrasonic Surgical Aspiration System (Compatible for 110/220 or 230V)
• 00841626101630: SonaStar FS 1000 RF Ultrasonic Surgical Aspiration System (Compatible for 110/220 or 230V)
• 00841626101623: SonaStar FS 1000 RF Ultrasonic Surgical Aspiration System (Compatible for 110/220 or 230V)
• 00841626101616: SonaStar FS 1000 RF Ultrasonic Surgical Aspiration System (Compatible for 110/220 or 230 V)
• 00841626101609: SonaStar FS 1000 RF Ultrasonic Surgical Aspiration System (Compatible for 110/220 or 230V)
• 00841626101593: SonaStar FS 1000 RF Ultrasonic Surgical Aspiration System (Compatible for 110/220 or 230 V)
• 00841626101586: SonaStar FS 1000 RF Ultrasonic Surgical Aspiration System (Compatible for 100/200 V)
• 00841626101579: SonaStar FS 1000 RF Ultrasonic Surgical Aspiration System (Compatible for 100/200 V)
• 00841626101562: SonaStar FS 1000 RF Ultrasonic Surgical Aspiration System (Compatible for 100/200 V)
• 00841626101555: SonaStar FS 1000 RF Ultrasonic Surgical Aspiration System (Compatible for 100/200 V)
• 00841626101548: SonaStar FS 1000 RF Ultrasonic Surgical Aspiration System (Compatible for 100/200 V)
• 00841626101531: SonaStar FS 1000 RF Ultrasonic Surgical Aspiration System (Compatible for 100/200 V)
• 00841626101524: SonaStar FS 1000 RF Ultrasonic Surgical Aspiration System (Compatible for 100/200 V)