Nucleotome 11000

GUDID B067110000

Nucleotome Console

CLARUS MEDICAL, LLC

Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic

• Primary Device ID: B067110000
• NIH Device Record Key: d40491a8-7ed4-4a3f-b3ee-546fe4ea3d7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nucleotome
• Version Model Number: 11000
• Catalog Number: 11000
• Company DUNS: 010316284
• Company Name: CLARUS MEDICAL, LLC
• Device Count: 1
• DM Exempt: true
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 98 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 98 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B067110000 [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: false

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