BoneScalpel

GUDID 00841626100664

BoneScalpel Ultrasonic Surgical Aspiration System/Generator

MISONIX, INC.

Hard-tissue ultrasonic surgical system

• Primary Device ID: 00841626100664
• NIH Device Record Key: 5dc210b2-e20c-4ec6-ad66-efc04cc1b31d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BoneScalpel
• Version Model Number: BCM-GN
• 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	00841626100664 [Primary]

FDA Product Code

• LFL: Instrument, Ultrasonic Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-24
• Device Publish Date: 2016-09-24

On-Brand Devices [BoneScalpel]

• 10841626101262: BoneScalpel Irrigation Tubeset
• 10841626101255: BoneScalpel Irrigation Tubeset
• 10841626100753: BoneScalpel Irrigation Tubeset
• 00841626101265: BoneScalpel Irrigation Tubeset
• 00841626101258: Irrigation Tubeset
• 00841626100756: BoneScalpel Irrigation Tubeset
• 00841626102309: BONESCALPEL® MACRO HOOK SHAVER
• 00841626101999: BoneScalpel MicroHook, Long Curved Rigid Shaver
• 00841626101975: BoneScalpel 10mm, Long Curved Rigid Blunt Blade
• 00841626101487: BoneScalpel, 20mm Long CURVED Rigid Blunt Blade
• 00841626101234: BoneScalpel 4.4mm Diamond, Standard Shaver
• 00841626101210: BoneScalpel MicroHook, Standard Shaver
• 00841626101197: BoneScalpel 20mm, Standard Unilaterial Serrated Blade
• 00841626101173: BoneScalpel 25mm, Standard Blunt Blade
• 00841626101166: BoneScalpel 20mm, Long Curved Blunt Blade
• 00841626101142: BoneScalpel 20mm, Standard Blunt Blade
• 00841626101135: BoneScalpel 10mm, Long Straight Blunt Blade
• 00841626101128: Bone Scalpel 10mm, Long Curved Blunt Blade
• 00841626101104: BoneScalpel 10mm, Standard Blunt Blade
• 00841626102057: BoneScalpel Handpiece Kit COMPRISES OF BCM-HP, BCM-SS (MEDICAL DEVICE ) BCM-CBS, BCM-CBL, BCM-CW
• 00841626100732: BoneScalpel Probe Cover
• 00841626100688: BoneScalpel Handpiece
• 00841626100664: BoneScalpel Ultrasonic Surgical Aspiration System/Generator
• 00841626100640: BoneScalpel Footswitch
• 00841626100626: BoneScalpel Handpiece Wrench