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

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