Vaporflex®

GUDID 04250337104032

Vaporflex® Spare Sealing Rings for Handle

Joimax GmbH

Radio-frequency ablation system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system

• Primary Device ID: 04250337104032
• NIH Device Record Key: 2da799fa-6d03-4e6d-9e6e-82af2faab3ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vaporflex®
• Version Model Number: JVHP10023
• 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
• Phone: +49721255140
• Email: quality@joimax.com
• Phone: +49721255140
• Email: quality@joimax.com
• Phone: +49721255140
• Email: quality@joimax.com
• Phone: +49721255140
• Email: quality@joimax.com
• Phone: +49721255140
• Email: quality@joimax.com
• Phone: +49721255140
• Email: quality@joimax.com
• Phone: +49721255140
• Email: quality@joimax.com
• Phone: +49721255140
• Email: quality@joimax.com
• Phone: +49721255140
• Email: quality@joimax.com
• Phone: +49721255140
• Email: quality@joimax.com
• Phone: +49721255140
• Email: quality@joimax.com
• Phone: +49721255140
• Email: quality@joimax.com
• Phone: +49721255140
• Email: quality@joimax.com
• Phone: +49721255140
• Email: quality@joimax.com
• Phone: +49721255140
• Email: quality@joimax.com
• Phone: +49721255140
• Email: quality@joimax.com
• Phone: +49721255140
• Email: quality@joimax.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250337104032 [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

[04250337104032]

Moist Heat or Steam Sterilization

[04250337104032]

Moist Heat or Steam Sterilization

[04250337104032]

Moist Heat or Steam Sterilization

[04250337104032]

Moist Heat or Steam Sterilization

[04250337104032]

Moist Heat or Steam Sterilization

[04250337104032]

Moist Heat or Steam Sterilization

[04250337104032]

Moist Heat or Steam Sterilization

[04250337104032]

Moist Heat or Steam Sterilization

[04250337104032]

Moist Heat or Steam Sterilization

[04250337104032]

Moist Heat or Steam Sterilization

[04250337104032]

Moist Heat or Steam Sterilization

[04250337104032]

Moist Heat or Steam Sterilization

[04250337104032]

Moist Heat or Steam Sterilization

[04250337104032]

Moist Heat or Steam Sterilization

[04250337104032]

Moist Heat or Steam Sterilization

[04250337104032]

Moist Heat or Steam Sterilization

[04250337104032]

Moist Heat or Steam Sterilization

[04250337104032]

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®