Duns Number:809784593
Device Description: Kaltostat® Alginate Wound Dressing - 3" X 4 3/4"
Catalog Number
168212
Brand Name
KALTOSTAT
Version/Model Number
168212
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
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
NAC
Product Code Name
Dressing, Wound, Hydrophilic
Public Device Record Key
a3fef887-2696-4ce8-8433-99607a7cec97
Public Version Date
October 28, 2022
Public Version Number
2
DI Record Publish Date
September 06, 2022
Package DI Number
00768455102273
Quantity per Package
10
Contains DI Package
00768455122790
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 116 |
| U | Unclassified | 8 |