Duns Number:200564891
Device Description: Hydrophilic Wound Dressing with Zinc Plus Vitamins A and B6 For Skin Ulcers (Diabetic, Ven Hydrophilic Wound Dressing with Zinc Plus Vitamins A and B6 For Skin Ulcers (Diabetic, Venous Stasis), and Stage I-IV Pressure Sores
Catalog Number
DERMA-SPD03
Brand Name
DERMAGRAN®-B
Version/Model Number
SPD-03
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K954739,K954739
Product Code
MGP
Product Code Name
DRESSING, WOUND AND BURN, OCCLUSIVE
Public Device Record Key
1a794df9-ed80-416d-b0cb-85922ed3d2e7
Public Version Date
July 22, 2021
Public Version Number
3
DI Record Publish Date
October 23, 2018
Package DI Number
30381780491815
Quantity per Package
12
Contains DI Package
10381780491811
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 | 254 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |
| U | Unclassified | 42 |