Duns Number:657476292
Device Description: Anscare Hydrocolloid Dressings(Sterile) are hydrophilic, occlusive dressings. The flexible Anscare Hydrocolloid Dressings(Sterile) are hydrophilic, occlusive dressings. The flexible outer layer helps isolate the wound against bacterial and other external contamination while the dressing remains intact without leakage. The inner layer maintains a moist wound environment while absorbing excess wound exudate to prevent fluid pooling.
Catalog Number
-
Brand Name
Anscare Hydrocolloid Dressing(Sterile)
Version/Model Number
HS-330-2
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)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NAE
Product Code Name
Dressing, Wound, Hydrogel Without Drug And/Or Biologic
Public Device Record Key
9aacdf64-4270-4df9-bfaa-2897fa1f4c5e
Public Version Date
September 27, 2022
Public Version Number
1
DI Record Publish Date
September 19, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 12 |