Nucleotome 23535

GUDID B067235351

3.5 MM Kit with aspiration bottle

CLARUS MEDICAL, LLC

Diskectomy system, percutaneous, automatic

• Primary Device ID: B067235351
• NIH Device Record Key: 7ba2dde2-4d63-4999-98a0-6932bb6fab82
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nucleotome
• Version Model Number: 23535
• Catalog Number: 23535
• Company DUNS: 010316284
• Company Name: CLARUS MEDICAL, LLC
• Device Count: 2
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 763-525-8400
• Email: admin@clarus-medical.com
• Phone: 763-525-8400
• Email: admin@clarus-medical.com

Device Dimensions

• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B067235350 [Unit of Use]
HIBCC	B067235351 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K844131

FDA Product Code

• HSZ: Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-20

On-Brand Devices [Nucleotome]

• B067235351: 3.5 MM Kit with aspiration bottle
• B067235001: 2.5 MM Kit with aspiration bottle
• B067225001: 2.0 MM Kit with aspiration bottle
• B067212001: 2.0 MM Short Kit with aspiration bottle
• B067110000: Nucleotome Console