neXus

GUDID 00841626103351

neXus BoneScalpel® Standard Decompression Kit (20mm blade, micro hook shaver & Tubeset)

MISONIX, INC.

Hard-tissue ultrasonic surgical system handpiece tip

• Primary Device ID: 00841626103351
• NIH Device Record Key: 5df3873d-b131-423e-9232-6a9445a3fb9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: neXus
• Version Model Number: 110-31-5501
• 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• 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	00841626103054 [Primary]
GS1	00841626103351 [Package]; Contains: 00841626103054; Package: box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190160

FDA Product Code

• LFL: Instrument, Ultrasonic Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-03
• Device Publish Date: 2020-02-24

On-Brand Devices [neXus]

• 00841626103535: neXus SonaStar® 2.6mm Macro Short Tip & Tubeset
• 00841626103528: neXus SonaStar® 1.9mm x 30cm Long Laparoscopic Tip & Tubeset
• 00841626103511: neXus SonaStar® 1.9mm Notched, Standard Short Tip & Tubeset
• 00841626103504: neXus SonaStar1.9mm Standard Short Tip & Tubeset
• 00841626103498: neXus SonaStar® 1.6mm Micro Short Tip & Tubeset
• 00841626103481: neXus SonaStar® 1.1mm Precision Short Tip & Tubeset
• 00841626103474: neXus SonaStar® Cylindrical Shaver Short Tip & Tubeset
• 00841626103450: neXus SonaStar® 1.9mm Deep Access Standard Long Tip & Tubeset
• 00841626103467: neXus SonaStar® 1.9mm Standard Long Curved Tip & Tubeset
• 00841626103443: neXus SonaStar® 1.6mm Micro Long Curved Tip & Tubeset
• 00841626103436: neXus SonaStar® 1.1 mm Precision Long Curved Tip & Tubeset
• 00841626103429: neXus SonaStar® Micro Hook Shaver Long Tip & Tubeset
• 00841626103412: neXus SonicOne® O.R. SonicVac & Tubeset
• 00841626103405: neXus SonicOne® O.R. SonicVac & Tubeset
• 00841626103399: neXus SonicOne® O.R. Hatched Probe & Tubeset
• 00841626103382: neXus SonicOne® O.R. SonicVac & Tubeset
• 00841626103351: neXus BoneScalpel® Standard Decompression Kit (20mm blade, micro hook shaver & Tubeset)
• 00841626103344: neXus BoneScalpel® Micro Hook MIS Shaver & Tubeset
• 00841626103337: neXus BoneScalpel® 20mm MIS, Blunt Blade, Sheath & Tubeset
• 00841626103320: neXus BoneScalpel® 10mm MIS, Blunt Blade, Sheath & Tubeset
• 00841626103313: neXus BoneScalpel® Diamond Shaver & Tubeset
• 00841626103306: neXus BoneScalpel® Macro Hook Shaver & Tubeset
• 00841626103290: neXus BoneScalpel® Micro Hook Shaver & Tubeset
• 00841626103283: neXus BoneScalpel® 25mm, Blunt Blade & Tubeset
• 00841626103276: neXus BoneScalpel® 20mm, Uni-lateral Serrated Blade & Tubeset
• 00841626103269: neXus BoneScalpel® 20mm, Blunt Blade & Tubeset
• 00841626103252: neXus BoneScalpel® 10mm, Blunt Blade & Tubeset
• 00841626103245: neXus SonaStar® Monopolar Hand Switch Cable
• 00841626102910: neXus SonaStar® Handpiece Kit (Long)
• 00841626102903: neXus SonaStar® Handpiece Kit (Short)
• 00841626102897: neXus SonaStar® Lap Housing (Short)
• 00841626102880: neXus SonaStar® Short Housing
• 00841626102873: neXus SonaStar® Long Housing
• 00841626102866: neXus SonaStar® Front Housing (Long)
• 00841626102859: neXus SonaStar® Mid-Housing (Long)
• 00841626102712: neXus Handpiece Kit (BoneScalpel or SonicOne OR)
• 00841626102668: neXus SonicOne® O.R. Standard Front Housing
• 00841626102651: neXus BoneScalpel® Standard Front Housing
• 00841626102613: neXus SonaStar® Sterilization Tray
• 00841626102606: neXus Standard Sterilization Tray
• 00841626102590: neXus SonaStar® Handpiece Torque Wrench
• 00841626102583: neXus SonaStar® Handpiece Counter Wrench
• 00841626102576: neXus Standard Handpiece Torque Wrench
• 00841626102569: neXus Standard Handpiece Counter Wrench
• 00841626102545: neXus SonaStar® Long Handpiece
• 00841626102538: neXus SonaStar® Short Handpiece
• 00841626102521: neXus Standard Handpiece
• 00841626102484: neXus Wireless Footpedal
• 00841626102453: neXus Ultrasonic Surgical Aspirator System/Console
• 00841626102835: neXus Suction Canister