Duns Number:008124539
Device Description: DynaGinate AG Silver Calcium Alginate, 4" x 8" (10cm x 20cm), High Absorbency, For Wound S DynaGinate AG Silver Calcium Alginate, 4" x 8" (10cm x 20cm), High Absorbency, For Wound Stages 3,4
Catalog Number
-
Brand Name
DynaGinate AG Silver Calcium Alginate
Version/Model Number
3032
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
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
8f32f6f4-fd15-4124-85d2-af79bd12c01f
Public Version Date
May 03, 2022
Public Version Number
1
DI Record Publish Date
April 25, 2022
Package DI Number
00616784303222
Quantity per Package
5
Contains DI Package
00616784303215
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 694 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |
| 3 | A medical device with high risk that requires premarket approval | 2 |