Duns Number:080935429
Device Description: True content to be populated as part of rebranding
Catalog Number
2290-
Brand Name
Dermacea
Version/Model Number
2290
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 17, 2022
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
FQM
Product Code Name
BANDAGE, ELASTIC
Public Device Record Key
eeabe5c5-b5a4-4c8f-8feb-70d8f9fb5dee
Public Version Date
April 18, 2022
Public Version Number
4
DI Record Publish Date
August 23, 2019
Package DI Number
10884521143791
Quantity per Package
8
Contains DI Package
20884521143798
Package Discontinue Date
April 17, 2022
Package Status
Not in Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |