Dash-Topic

GUDID 00383160001002

Dash-Topic Plus Cream

AIM MEDICAL INC.

Dry skin moisture barrier dressing
Primary Device ID00383160001002
NIH Device Record Key323234eb-2aeb-4014-8398-89603c98dd83
Commercial Distribution StatusIn Commercial Distribution
Brand NameDash-Topic
Version Model Number100g
Company DUNS117589740
Company NameAIM MEDICAL INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100383160001002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-04-25
Device Publish Date2023-01-19

On-Brand Devices [Dash-Topic]

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.