Joimax® Intracs® EM Field Generator

GUDID 04250337116561

Joimax GmbH

Electromagnetic surgical navigation device tracking system

• Primary Device ID: 04250337116561
• NIH Device Record Key: 7911ca75-b481-432a-afca-9c3c3d54dc60
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Joimax® Intracs® EM Field Generator
• Version Model Number: JINTFG1125
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250337116561 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192663

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-22
• Device Publish Date: 2021-11-12

Devices Manufactured by Joimax GmbH

• 04250337118312 - Vaporace®/Vaporgrip® Kabel, L 3,0 m: 2025-02-24
• 04250337118619 - Vaporace® Probe bipolar, Area 270 mm – 3.5 mm: 2025-02-24
• 04250337118640 - Vaporace® Probe bipolar, Area 320 mm – 3.5 mm: 2025-02-24
• 04250337118978 - Vaporace® Hand Piece, bipolar: 2025-02-24
• 04250337120230 - Vaporace® Probe bipolar, Area 150 mm – 3.5 mm: 2025-02-24
• 04250337101741 - iLESSYS®: 2024-09-11 TESSYS® Steel Ruler
• 04250337102854 - Adapter: 2024-07-15 Lightsource Adaptor for Foraminoscope (Wolf)
• 04250337102861 - Adapter: 2024-07-15 Lightsource Adaptor for Foraminoscope (Storz)