Duns Number:809784593
Device Description: DuoDERM Hydroactive Dressing, 4 x 4 in
Catalog Number
-
Brand Name
DUODERM
Version/Model Number
187611
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 20, 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)
Yes
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
27bdea5c-0b18-434c-acda-6dfb436a2492
Public Version Date
May 23, 2022
Public Version Number
4
DI Record Publish Date
April 12, 2019
Package DI Number
10768455106933
Quantity per Package
5
Contains DI Package
00768455106936
Package Discontinue Date
May 20, 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 | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 116 |
| U | Unclassified | 8 |