Vaporace® Probe bipolar, Area 320 mm – 3.5 mm

GUDID 04250337118640

Joimax GmbH

Electrosurgical system

• Primary Device ID: 04250337118640
• NIH Device Record Key: 2a15f1c3-b892-418c-82d1-0178d9639204
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vaporace® Probe bipolar, Area 320 mm – 3.5 mm
• Version Model Number: JVAPA32035
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250337118633 [Primary]
GS1	04250337118640 [Package]; Contains: 04250337118633; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161378

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-24
• Device Publish Date: 2025-02-14

Devices Manufactured by Joimax GmbH

• 04250337120759 - deflector: 2025-08-04 Deflector Spinner Blade, 9 mm
• 04250337120766 - deflector: 2025-08-04 Deflector Spinner Blade, 12 mm
• 04250337120773 - deflector: 2025-08-04 Deflector Spinner Blade, 9 mm
• 04250337120780 - deflector: 2025-08-04 Deflector Spinner Blade, 12 mm
• 04250337120797 - deflector: 2025-08-04 AO Spinner Blade, 9 mm
• 04250337120803 - deflector: 2025-08-04 AO Spinner Blade, 12 mm
• 04250337119630 - Endo-Chisel, with handle: 2025-04-01 Bone Ablating Instruments (Curettes, Dissectors and Chisels) are hand-held manual surgical instruments, used to dissect or scrap
• 04250337110569 - Semi-Flexible Biopsy Forceps, up-biting: 2025-03-25 Forceps are used during minimally invasive spinal surgery for the removal of soft tissue, loose tissue fragments and herniated d