Duns Number:084733682
Device Description: #5 Oval PolyMem Silicone Border Silver Dressing
Catalog Number
1285
Brand Name
PolyMem
Version/Model Number
Silicone Silver Border
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
-
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
49af15bd-de49-4177-b0e3-4178be0a201a
Public Version Date
September 08, 2020
Public Version Number
1
DI Record Publish Date
August 31, 2020
Package DI Number
20735471012859
Quantity per Package
5
Contains DI Package
10735471012852
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box