Vaporflex®

GUDID 04250337103899

Vaporflex® Handle

Joimax GmbH

Radio-frequency ablation system

• Primary Device ID: 04250337103899
• NIH Device Record Key: 6207505b-4389-470f-b200-65b99605e716
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vaporflex®
• Version Model Number: JVUH10010
• 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: 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	04250337103899 [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

[04250337103899]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-08

On-Brand Devices [Vaporflex®]

• 04250337117520: Vaporflex® KIT2 short for joimax® Endovapor® 2
• 04250337117513: Vaporflex® KIT1 short for joimax® Endovapor®
• 04250337116790: Vaporflex® Handle and Shaft
• 04250337116783: Vaporflex® Shaft 275
• 04250337116271: Vaporflex® Probe 275, Ball Tip, Bipolar
• 04250337113867: Vaporflex® Shaft 250
• 04250337113850: Vaporflex® Probe 250, Ball Tip, Bipolar
• 04250337105206: Vaporflex® Probe 275, bipolar, sterile
• 04250337104056: Vaporflex® Irrigation Shaft 275
• 04250337104032: Vaporflex® Spare Sealing Rings for Handle
• 04250337103905: Vaporflex® Cable L 3.5 m
• 04250337103899: Vaporflex® Handle
• 04250337103882: Vaporflex® Shaft 320
• 04250337103875: Vaporflex® Handle and Shaft 320
• 04250337103844: Vaporflex® Probe 320, Ball Tip, bipolar
• 04250337114413: Vaporflex® KIT2 Short for joimax® Endovapor®2
• 04250337114406: Vaporflex® KIT1 Short for joimax® Endovapor®
• 04250337114390: Vaporflex® Set 275 for intENTS® lumbar System
• 04250337114383: Vaporflex® Set 250 for iLESSYS® Systems
• 04250337112631: Vaporflex® KIT2 for joimax® Endovapor®2, complete
• 04250337112624: Vaporflex® KIT2 S for joimax® Endovapor®2
• 04250337109563: Vaporflex® KIT1 S for joimax® Endovapor®
• 04250337105695: Vaporflex® KIT1 for joimax® Endovapor®
• 04250337104049: Vaporflex® Cable L 3.5 m
• 04250337103912: Vaporflex® Cable L 3.5 m
• 04250337120100: Vaporflex® Probe 320, Ball Tip, bipolar
• 04250337103585: Vaporflex® KIT 2 for joimax® Endovapor®2
• 04250337103578: Vaporflex® KIT 1 for joimax® Endovapor®