Model 5150-002 Tubing Set 5150-002

GUDID B06751500020

Tubing Set

CLARUS MEDICAL, LLC

Surgical irrigation tubing set, single-use Surgical irrigation tubing set, single-use

• Primary Device ID: B06751500020
• NIH Device Record Key: 1f6f9ea9-9396-49a0-9a72-4edeccd0addd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Model 5150-002 Tubing Set
• Version Model Number: 5150-002
• Catalog Number: 5150-002
• 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: 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	B06751500020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K912447

FDA Product Code

• FET: Endoscopic Video Imaging System/Component, Gastroenterology-Urology

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-23
• Device Publish Date: 2016-09-22

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