Duns Number:118744421
Device Description: Non Adhesive Foam Dressing, PU Waterproof 4" x 4"
Catalog Number
FD002
Brand Name
CALICO
Version/Model Number
FD002
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NAC
Product Code Name
Dressing, Wound, Hydrophilic
Public Device Record Key
b9193498-33e2-4834-8f94-d6e97264ecba
Public Version Date
August 30, 2022
Public Version Number
1
DI Record Publish Date
August 22, 2022
Package DI Number
20850044458565
Quantity per Package
20
Contains DI Package
00850044458561
Package Discontinue Date
-
Package Status
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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |
| U | Unclassified | 1 |