Duns Number:305524696
Device Description: Comfeel Plus Hydrocolloid Dressing, Sacral. Dressing Length 17 cm, Dressing Length 7 in, D Comfeel Plus Hydrocolloid Dressing, Sacral. Dressing Length 17 cm, Dressing Length 7 in, Dressing Width 17 cm, Dressing Width 7 in.
Catalog Number
33285
Brand Name
Comfeel Plus
Version/Model Number
33285
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)
-
Over the Counter (OTC)
Yes
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
93a2f72a-18c7-4c2d-8bbc-712edd9b10dd
Public Version Date
March 21, 2022
Public Version Number
1
DI Record Publish Date
March 11, 2022
Package DI Number
05708932641531
Quantity per Package
5
Contains DI Package
05708932641524
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Retail Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 46 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 899 |
| 3 | A medical device with high risk that requires premarket approval | 72 |
| U | Unclassified | 7 |