Duns Number:027680821
Device Description: The dressings are intended for wound care applications and securing objects to the skin.
Catalog Number
-
Brand Name
Aspen® Transparent Border Dressing
Version/Model Number
TDS-24
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NAD
Product Code Name
Dressing, wound, occlusive
Public Device Record Key
9791f940-c015-404e-8541-175fca0affd9
Public Version Date
March 05, 2021
Public Version Number
1
DI Record Publish Date
February 25, 2021
Package DI Number
20840113230499
Quantity per Package
4
Contains DI Package
10840113230492
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 952 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 494 |