Dash-Topic

GUDID 00383160001002

Dash-Topic Plus Cream

AIM MEDICAL INC.

Dry skin moisture barrier dressing

• Primary Device ID: 00383160001002
• NIH Device Record Key: 323234eb-2aeb-4014-8398-89603c98dd83
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dash-Topic
• Version Model Number: 100g
• 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	00383160001002 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-04-25
• Device Publish Date: 2023-01-19

On-Brand Devices [Dash-Topic]

• 00383160001019: Dash-Topic Plus Cream, 50g
• 00383160001002: Dash-Topic Plus Cream