LASE Endoscopic Discectomy Set 1100-002(S)

GUDID B0671100002S0

LASE Endoscopic Discectomy Set (Short), with Tubing Set. For use with HO:YAG Lasers with a SMA 905 connector.

CLARUS MEDICAL, LLC

Lumbar decompression procedure kit Lumbar decompression procedure kit

• Primary Device ID: B0671100002S0
• NIH Device Record Key: 756a2271-c748-4ddf-9f07-953c2e8ae1c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LASE Endoscopic Discectomy Set
• Version Model Number: 1100-002(S)
• Catalog Number: 1100-002(S)
• 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: false
• Serial Number: true
• 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

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	B0671100002S0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040424

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: 2016-09-20

On-Brand Devices [LASE Endoscopic Discectomy Set]

• B0671100010L0: LASE Endoscopic Discectomy System (Long), with Tubing Set. For use with HO:YAG lasers with a Tr
• B06711000100: LASE Endoscopic Discectomy System, with Tubing Set. For use with HO:YAG lasers with a Trimedyne
• B0671100002SHORT0: LASE Endoscopic Discectomy Set (Short), with Tubing Set. For use with HO:YAG Lasers with a SMA
• B0671100002S0: LASE Endoscopic Discectomy Set (Short), with Tubing Set. For use with HO:YAG Lasers with a SMA
• B06711000020: LASE Endoscopic Discectomy Set, with Tubing Set. For use with HO:YAG Lasers with a SMA 905 conn