Duns Number:216344051
Device Description: Calcium Alginate Wound Dressing
Catalog Number
59480400
Brand Name
ALGISITE M 3/4X12" CTN 10
Version/Model Number
59480400
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)
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
4dd0635c-5493-4232-923f-7fb599cebc3f
Public Version Date
July 22, 2021
Public Version Number
5
DI Record Publish Date
May 15, 2020
Package DI Number
00040565118338
Quantity per Package
10
Contains DI Package
05000223425272
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 63 |
2 | A medical device with a moderate to high risk that requires special controls. | 126 |
U | Unclassified | 1 |