Instrument PI starter kit FS-295#

GUDID 07613353336790

Instrument PI starter kit

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

Ultrasonic dental scaling/debridement system

• Primary Device ID: 07613353336790
• NIH Device Record Key: 4137df08-5628-4096-b18d-a72cca0f63a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Instrument PI starter kit
• Version Model Number: FS-295#
• Catalog Number: FS-295#
• 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
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613353336790 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132445

FDA Product Code

• ELC: Scaler, Ultrasonic

Sterilization

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

[07613353336790]

Moist Heat or Steam Sterilization

[07613353336790]

Moist Heat or Steam Sterilization

[07613353336790]

Moist Heat or Steam Sterilization

[07613353336790]

Moist Heat or Steam Sterilization

[07613353336790]

Moist Heat or Steam Sterilization

[07613353336790]

Moist Heat or Steam Sterilization

[07613353336790]

Moist Heat or Steam Sterilization

[07613353336790]

Moist Heat or Steam Sterilization

[07613353336790]

Moist Heat or Steam Sterilization

[07613353336790]

Moist Heat or Steam Sterilization

[07613353336790]

Moist Heat or Steam Sterilization

[07613353336790]

Moist Heat or Steam Sterilization

[07613353336790]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-01
• Device Publish Date: 2025-04-23

On-Brand Devices [Instrument PI starter kit]

• 07613353086749: Instrument PI starter kit
• 07613353336790: Instrument PI starter kit