Clarus Digital Control Module 5190-500

GUDID 00810004821019

Clarus Digital Control Module

CLARUS MEDICAL, LLC

Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system

• Primary Device ID: 00810004821019
• NIH Device Record Key: 360c4eb5-404c-48a9-a9f4-56a369648f5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clarus Digital Control Module
• Version Model Number: 5190-500
• Catalog Number: 5190-500
• Company DUNS: 010316284
• Company Name: CLARUS MEDICAL, LLC
• 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: 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
• Phone: 763-525-8400
• Email: admin@clarus-medical.com
• Phone: 763-525-8400
• Email: admin@clarus-medical.com
• Phone: 763-525-8400
• Email: admin@clarus-medical.com
• Phone: 763-525-8400
• Email: admin@clarus-medical.com
• Phone: 763-525-8400
• Email: admin@clarus-medical.com
• Phone: 763-525-8400
• Email: admin@clarus-medical.com
• Phone: 763-525-8400
• Email: admin@clarus-medical.com
• Phone: 763-525-8400
• Email: admin@clarus-medical.com
• Phone: 763-525-8400
• Email: admin@clarus-medical.com
• Phone: 763-525-8400
• Email: admin@clarus-medical.com
• Phone: 763-525-8400
• Email: admin@clarus-medical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810004821019 [Direct Marking]
GS1	10810004821016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223615

FDA Product Code

• GWG: Endoscope, Neurological

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-27
• Device Publish Date: 2024-02-19

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