Dash Topic

GUDID 00383160000012

Dash Topic Plus Cream

AIM MEDICAL INC.

Dry skin moisture barrier dressing

• Primary Device ID: 00383160000012
• NIH Device Record Key: be2f4c55-796a-4009-addd-5763b30a8443
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dash Topic
• Version Model Number: 001
• Company DUNS: 117589740
• Company Name: AIM MEDICAL INC.
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00383160000012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150914

FDA Product Code

• MGQ: Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

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: 2024-05-03
• Device Publish Date: 2024-04-25

On-Brand Devices [Dash Topic]

• 00383160000012: Dash Topic Plus Cream
• 00383160000098: Dash Topic Lite Cream, 15g
• 00383160000029: Dash Topic Lite Cream, 50g