Duns Number:830016148
Device Description: Nexcare™ Acne Cover AC-108
Catalog Number
AC-108
Brand Name
3M™ Nexcare™
Version/Model Number
AC-108
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NAC
Product Code Name
Dressing, wound, hydrophilic
Public Device Record Key
77a4f1ab-7fdb-4a99-9ef8-2cf55cb58354
Public Version Date
July 22, 2021
Public Version Number
3
DI Record Publish Date
September 25, 2018
Package DI Number
50051131216704
Quantity per Package
30
Contains DI Package
30051131216700
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 274 |
2 | A medical device with a moderate to high risk that requires special controls. | 444 |
U | Unclassified | 7 |