Duns Number:084733682
Device Description: PolyMem Silicone Border Sacral Dressing
Catalog Number
2839
Brand Name
PolyMem
Version/Model Number
Silicone 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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KMF
Product Code Name
Bandage, Liquid
Public Device Record Key
82d02129-3306-4734-a5df-705c8e161e40
Public Version Date
April 08, 2021
Public Version Number
1
DI Record Publish Date
March 31, 2021
Package DI Number
20735471028393
Quantity per Package
5
Contains DI Package
10735471028396
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box