LASE Curved Operating Channel Set 1100-905

GUDID B06711009051

LASE Curved Operating Channel Set for use with 1100-002 or 1100-010 Endoscopes.

CLARUS MEDICAL, LLC

Lumbar decompression procedure kit

• Primary Device ID: B06711009051
• NIH Device Record Key: 476f65d7-836c-4049-b9f0-1a0b3e1b6b98
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LASE Curved Operating Channel Set
• Version Model Number: 1100-905
• Catalog Number: 1100-905
• Company DUNS: 010316284
• Company Name: CLARUS MEDICAL, LLC
• Device Count: 2
• 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 Dimensions

• Outer Diameter: 2.7 Millimeter
• Length: 19.9 Centimeter
• Outer Diameter: 2.7 Millimeter
• Length: 19.9 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B06711009050 [Unit of Use]
HIBCC	B06711009051 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K922881

FDA Product Code

• GEX: Powered Laser Surgical Instrument

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: 2016-09-22

Devices Manufactured by CLARUS MEDICAL, LLC

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• 00810004820326 - Forceps, Cup with Teeth, 2.0mm x 19.5cm, Down: 2025-01-07 Forceps, Cup with Teeth, 2.0mm x 19.5cm, Down
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• 00810004820777 - Forceps, Grasping, Down, 2mm, 19.7cm: 2025-01-07 Forceps, Grasping, Down, 2mm, 19.7cm
• 00810004820784 - Forceps, Grasping, Down, 2mm, 28.5cm: 2025-01-07 Forceps, Grasping, Down, 2mm, 28.5cm
• 00810004820876 - Forceps, Grasping, Down, 3mm, 28.5cm: 2025-01-07 Forceps, Grasping, Down, 3mm, 28.5cm