SONOGEL

GUDID 04262477320197

Gel bottle

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

Skin topical coupling gel

• Primary Device ID: 04262477320197
• NIH Device Record Key: 2f47efeb-abb0-48c3-a2cb-176436c739c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SONOGEL
• Version Model Number: DV-155
• 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: false
• 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

Device Dimensions

• Total Volume: 250 Milliliter
• Total Volume: 250 Milliliter
• Total Volume: 250 Milliliter
• Total Volume: 250 Milliliter
• Total Volume: 250 Milliliter
• Total Volume: 250 Milliliter
• Total Volume: 250 Milliliter
• Total Volume: 250 Milliliter
• Total Volume: 250 Milliliter
• Total Volume: 250 Milliliter
• Total Volume: 250 Milliliter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Between 5°C and 28°C with humidity levels from 15% to 80%
• Special Storage Condition, Specify: Between 0 and 0 *Between 5°C and 28°C with humidity levels from 15% to 80%
• Special Storage Condition, Specify: Between 0 and 0 *Between 5°C and 28°C with humidity levels from 15% to 80%
• Special Storage Condition, Specify: Between 0 and 0 *Between 5°C and 28°C with humidity levels from 15% to 80%
• Special Storage Condition, Specify: Between 0 and 0 *Between 5°C and 28°C with humidity levels from 15% to 80%
• Special Storage Condition, Specify: Between 0 and 0 *Between 5°C and 28°C with humidity levels from 15% to 80%
• Special Storage Condition, Specify: Between 0 and 0 *Between 5°C and 28°C with humidity levels from 15% to 80%
• Special Storage Condition, Specify: Between 0 and 0 *Between 5°C and 28°C with humidity levels from 15% to 80%
• Special Storage Condition, Specify: Between 0 and 0 *Between 5°C and 28°C with humidity levels from 15% to 80%
• Special Storage Condition, Specify: Between 0 and 0 *Between 5°C and 28°C with humidity levels from 15% to 80%
• Special Storage Condition, Specify: Between 0 and 0 *Between 5°C and 28°C with humidity levels from 15% to 80%

Device Identifiers

Device Issuing Agency	Device ID
GS1	04262477320197 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220538

FDA Product Code

• ISA: Massager, Therapeutic, Electric

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-10
• Device Publish Date: 2025-09-02

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

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• 04262477320197 - SONOGEL: 2025-09-10 Gel bottle
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• 07613353342074 - AIR-FLOW: 2025-07-15 PERIOFLOW HP WHITE
• 07613353343965 - AIR-FLOW: 2025-07-15 AIRFLOW MAX Introduction Kit
• 07613353337353 - PIEZON: 2025-06-18 Instrument A with combitorque
• 07613353337360 - PIEZON: 2025-06-18 Instrument A x3
• 07613353337377 - PIEZON: 2025-06-18 Instrument P with combitorque