Duns Number:091449079
Device Description: Drain Pad Dressing 2in x 2in with 12 mm access (DPD-20-12)
Catalog Number
-
Brand Name
Silverlon Antimicrobial Drain Pad Dressing
Version/Model Number
DPD-20-12
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)
Yes
Over the Counter (OTC)
Yes
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
e3f91869-0e80-46eb-9fdf-5b0c080f47f9
Public Version Date
December 08, 2020
Public Version Number
1
DI Record Publish Date
November 30, 2020
Package DI Number
10857278000648
Quantity per Package
5
Contains DI Package
00857278000641
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 13 |
| U | Unclassified | 100 |