AIR-FLOW - PIEZON EK-169

GUDID 07613353113049

Multifunction foot pedal

E.M.S. Electro Medical Systems S.A.

Foot-switch, electrical

• Primary Device ID: 07613353113049
• NIH Device Record Key: a22ea2c6-42d9-49ba-9df7-e676f5fd2b0c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AIR-FLOW - PIEZON
• Version Model Number: d
• Catalog Number: EK-169
• Company DUNS: 481233849
• Company Name: E.M.S. Electro Medical Systems S.A.
• 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: +41229944700
• Email: udi@ems-ch.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613353113049 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082791

FDA Product Code

• EFB: Handpiece, Air-Powered, Dental

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-16

Devices Manufactured by E.M.S. Electro Medical Systems S.A.

• 07613353317423 - Piezon: 2025-02-28 PIEZON® NO PAIN Built in kit LED 24-32V DC / 24V AC 50-60Hz 18VA With EJ-120A/B, without EH-128 and external power supply + IFU
• 07613353317430 - Piezon: 2025-02-28 PIEZON® NO PAIN Built in kit LED 24-32V DC / 24V AC 50-60Hz 18VA With EJ-120A/B and EL-457, without EH-128 and external power s
• 07613353317447 - Piezon: 2025-02-28 PIEZON® NO PAIN Built in kit 24-32V DC / 24V AC 50-60Hz 18VA Ultrasonic dental scaling/debridement system With EJ-120A/B and EL
• 07613353317454 - Piezon: 2025-02-28 PIEZON® NO PAIN Built in kit 24-32V DC / 24V AC 50-60Hz 18VA Ultrasonic dental scaling/debridement system With EJ-120A/B, witho
• 07613353086749 - Instrument PI starter kit: 2024-12-04 Instrument PI starter kit
• 07613353221591 - AIR-FLOW: 2024-10-09 AIR-FLOW® handy 3.0 PERIO
• 07613353125929 - LITHOCLAST: 2024-09-11 Swiss LithoClast Trilogy Cart Repaired
• 07613353167073 - AIR-FLOW: 2024-06-03 AIR-FLOW PLUS