Duns Number:211352227
Device Description: Hydrocolloid Wound Dressing
Catalog Number
HCF204
Brand Name
NU-DERM®
Version/Model Number
HCF204
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"
Yes
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
60c2cbb9-5a58-48d9-9149-309d443bb164
Public Version Date
July 22, 2021
Public Version Number
4
DI Record Publish Date
September 24, 2019
Package DI Number
25051978003974
Quantity per Package
5
Contains DI Package
15051978003977
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 | 66 |
U | Unclassified | 12 |