Duns Number:694747496
Device Description: RenoCareTM Hydrocolloid Band has a two layer construction composed of an absorbent hydroco RenoCareTM Hydrocolloid Band has a two layer construction composed of an absorbent hydrocolloid matrix laminated to a breathable polyurethane film backing.Hydrocolloid matrix rapidly absorbs exudates to form a cohesive gel providing significantly higher absorbency than the leading competitive hydrocolloid. In addition to excellent absorbency, the breathable polyurethane film backing provides a consistently high rate of moisture vapor transmission. Together, these features ensure an optimal moist wound environment, minimize the chance for damage to healthy peri-wound skin and provide cost-effective wear time for up to seven days.
Catalog Number
-
Brand Name
RenoCare Spot
Version/Model Number
HD14EN46
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
2e813211-03f5-4827-a9ba-5125e33d9393
Public Version Date
July 22, 2021
Public Version Number
2
DI Record Publish Date
February 10, 2021
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 | 12 |