SonicOne O.R

GUDID 00841626102040

SonicOne O.R Handpiece Kit COMPRISES OF SOM-HP, BCM-H2 (MEDICAL DEVICE ) BCM-CBS, BCM-CBL, BCM-CW, E-PWRCH, BCM-UM-USB (NON-MEDICAL DEVICES)

MISONIX, INC.

Wound therapy ultrasound system handpiece

• Primary Device ID: 00841626102040
• NIH Device Record Key: 762c8d87-3d0f-4bb3-9142-5cff25ea0efd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SonicOne O.R
• Version Model Number: SOM-HP KIT
• 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	00841626102040 [Primary]

FDA Product Code

• LFL: Instrument, Ultrasonic Surgical

Sterilization

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

[00841626102040]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-11-28

On-Brand Devices [SonicOne O.R]

• 00841626101272: SonicOne O.R. Large Blade
• 00841626102040: SonicOne O.R Handpiece Kit COMPRISES OF SOM-HP, BCM-H2 (MEDICAL DEVICE ) BCM-CBS, BCM-CBL, BCM-C
• 00841626100671: SonicOne O.R Probe Cover