Vaporace® Hand Piece, bipolar

GUDID 04250337118978

Joimax GmbH

Electrosurgical system

• Primary Device ID: 04250337118978
• NIH Device Record Key: e41ff773-f2c8-4db3-9905-21160b5c2d7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vaporace® Hand Piece, bipolar
• Version Model Number: JVAH10010
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	04250337118978 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161378

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[04250337118978]

Moist Heat or Steam Sterilization

[04250337118978]

Moist Heat or Steam Sterilization

[04250337118978]

Moist Heat or Steam Sterilization

[04250337118978]

Moist Heat or Steam Sterilization

[04250337118978]

Moist Heat or Steam Sterilization

[04250337118978]

Moist Heat or Steam Sterilization

[04250337118978]

Moist Heat or Steam Sterilization

[04250337118978]

Moist Heat or Steam Sterilization

[04250337118978]

Moist Heat or Steam Sterilization

[04250337118978]

Moist Heat or Steam Sterilization

[04250337118978]

Moist Heat or Steam Sterilization

[04250337118978]

Moist Heat or Steam Sterilization

[04250337118978]

Moist Heat or Steam Sterilization

[04250337118978]

Moist Heat or Steam Sterilization

[04250337118978]

Moist Heat or Steam Sterilization

[04250337118978]

Moist Heat or Steam Sterilization

[04250337118978]

Moist Heat or Steam Sterilization

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

• 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
• 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)