iLESSYS®

GUDID 04250337109600

iLESSYS® Delta HD Laminoscope (6.0 mm WCh), combo

Joimax GmbH

Spinal endoscopic-access system

• Primary Device ID: 04250337109600
• NIH Device Record Key: e828f77c-3be7-43d8-b14e-a8e61d47fc91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iLESSYS®
• Version Model Number: LS1006125C
• Company DUNS: 344267187
• Company Name: Joimax GmbH
• 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: +49721255140
• Email: quality@joimax.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250337109600 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051827

FDA Product Code

• HRX: Arthroscope

Sterilization

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

[04250337109600]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [iLESSYS®]

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• 04250337116011: iLESSYS® Pro FHD Laminoscope (4.7 WCh), Combo
• 04250337109617: iLESSYS® Delta HD Laminoscope (6.0 mm WCh), ocular
• 04250337109600: iLESSYS® Delta HD Laminoscope (6.0 mm WCh), combo
• 04250337105763: iLESSYS® HD Laminoscope (3.7 mm WCh), ocular
• 04250337105756: iLESSYS® HD Laminoscope (3.7 mm WCh), combo
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• 04250337117612: TESSYS® Lid for DIN-Norm-Container
• 04250337117605: intENTS® Lid for DIN-Norm-Container
• 04250337117599: MultiZYTE® Lid for DIN-Norm-Container
• 04250337117582: iLESSYS® Lid for DIN-Norm-Container
• 04250337117575: CESSYS® Lid for DIN-Norm-Container
• 04250337110064: iLESSYS® DIN-Norm-Container, red Lid