Dash Topic

GUDID 00383160000012

Dash Topic Plus Cream

AIM MEDICAL INC.

Dry skin moisture barrier dressing Dry skin moisture barrier dressing Dry skin moisture barrier dressing Dry skin moisture barrier dressing Dry skin moisture barrier dressing Dry skin moisture barrier dressing Dry skin moisture barrier dressing Dry skin moisture barrier dressing Dry skin moisture barrier dressing Dry skin moisture barrier dressing 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

Devices Manufactured by AIM MEDICAL INC.

• 00383160000005 - ScarMD: 2024-05-03 ScarMD Silicone Scar Gel
• 00383160000012 - Dash Topic: 2024-05-03Dash Topic Plus Cream
• 00383160000012 - Dash Topic: 2024-05-03 Dash Topic Plus Cream
• 00860004589785 - ScarMD: 2024-05-02 ScarMD Silicone Scar Gel 6g Glide
• 00383160001002 - Dash-Topic: 2024-04-25 Dash-Topic Plus Cream
• 00383160001019 - Dash-Topic: 2024-04-25 Dash-Topic Plus Cream, 50g
• 00860004589778 - ScarMD: 2022-09-02 ScarMD Silicone Scar Gel 1g
• 00860004589716 - ScarMD: 2020-08-31 ScarMD silicone scar gel 15g Glide Massaging
• 00860004589723 - ScarMD: 2020-08-31 ScarMD Silicone Scar Gel 6g