Dash-Topic

GUDID 00383160001002

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 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	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