CESSYS®

GUDID 04250337114680

CESSYS® Dorsal FHD Laminoscope (4.7 WCh), ocular

Joimax GmbH

Spinal endoscopic-access system

• Primary Device ID: 04250337114680
• NIH Device Record Key: 4ddbaf68-bb6b-4818-971c-e8c478d8b4e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CESSYS®
• Version Model Number: LS7347068O
• 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	04250337114680 [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

[04250337114680]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-08

On-Brand Devices [CESSYS®]

• 04250337114697: CESSYS® Dorsal FHD Laminoscope (4.7 WCh), combo
• 04250337114680: CESSYS® Dorsal FHD Laminoscope (4.7 WCh), ocular
• 04250337105879: CESSYS® Cervical Hybrid Scope, combo
• 04250337116837: CESSYS® Dorsal DIN-Norm-Container, yellow Lid
• 04250337108818: CESSYS® DIN-Norm-Container, gold Lid
• 04250337105152: CESSYS® Cervical Reamer