Duns Number:043611421
Device Description: 7 x 10 cm Fenestrated Plus Biologic Wound Matrix
Catalog Number
-
Brand Name
MiroDerm Fenestrated Plus
Version/Model Number
BLM-200-03-0710
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K143426
Product Code
KGN
Product Code Name
Dressing, Wound, Collagen
Public Device Record Key
cb5177d6-d655-40a7-b50a-6dae7ef90d90
Public Version Date
October 08, 2020
Public Version Number
1
DI Record Publish Date
September 30, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 6 |
U | Unclassified | 16 |