Asonic Gel

GUDID 10848340014854

Ultrasound Transmission Gel

ADVANCE MEDICAL DESIGNS, INC.

Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel

• Primary Device ID: 10848340014854
• NIH Device Record Key: 67436dba-49d8-4334-b67c-baf2b9f36b28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Asonic Gel
• Version Model Number: ASG-001
• Company DUNS: 130785884
• Company Name: ADVANCE MEDICAL DESIGNS, INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848340014857 [Primary]
GS1	10848340014854 [Package]; Contains: 00848340014857; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163050

FDA Product Code

• MUI: Media, coupling, ultrasound

Sterilization

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

[10848340014854]

Radiation Sterilization

[10848340014854]

Radiation Sterilization

[10848340014854]

Radiation Sterilization

[10848340014854]

Radiation Sterilization

[10848340014854]

Radiation Sterilization

[10848340014854]

Radiation Sterilization

[10848340014854]

Radiation Sterilization

[10848340014854]

Radiation Sterilization

[10848340014854]

Radiation Sterilization

[10848340014854]

Radiation Sterilization

[10848340014854]

Radiation Sterilization

[10848340014854]

Radiation Sterilization

[10848340014854]

Radiation Sterilization

[10848340014854]

Radiation Sterilization

[10848340014854]

Radiation Sterilization

[10848340014854]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-21
• Device Publish Date: 2023-06-13

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• 10848340012089 - Sterile Elastic Bands: 2024-04-22 Sterile Elastic Bands
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