Duns Number:084733682
Device Description: 2" x 10" PolyMem MAX Adhesive Film Island Dressing
Catalog Number
3412
Brand Name
PolyMem
Version/Model Number
MAX
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
092d14c1-17a7-4c6f-900e-ec5db68fa3bd
Public Version Date
September 08, 2020
Public Version Number
1
DI Record Publish Date
August 31, 2020
Package DI Number
20735471034127
Quantity per Package
12
Contains DI Package
10735471034120
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box