Duns Number:631770658
Device Description: Mepilex Border Ag, 10x10cm, US
Catalog Number
-
Brand Name
Mepilex® Border Ag
Version/Model Number
395390
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K100029,K100029,K100029
Product Code
FRO
Product Code Name
Dressing, wound, drug
Public Device Record Key
dbc8e413-db41-4934-8f77-6e751ae37bba
Public Version Date
October 31, 2022
Public Version Number
1
DI Record Publish Date
October 21, 2022
Package DI Number
07332551822996
Quantity per Package
5
Contains DI Package
07332551816407
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PACK_OR_INNER_PACK
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 212 |
2 | A medical device with a moderate to high risk that requires special controls. | 15 |
U | Unclassified | 18 |