Duns Number:083171244
Device Description: INTEGRA Meshed Bilayer Wound Matrix is an advanced woundcare device comprised of a porous INTEGRA Meshed Bilayer Wound Matrix is an advanced woundcare device comprised of a porous matrix of cross-linked bovine tendon collagen and glycosaminoglycan and a semi-permeable polysiloxane (silicone) layer. The meshed bylayer matrix allows drainage of wound exudate and provides a flexible adherent covering for the wound surface. The collagen-glycosaminoglycan biodegradable matrix provides a scaffold for cellular invasion and capillary growth.
Catalog Number
MWM4101
Brand Name
INTEGRA Meshed Bilayer Wound Matrix
Version/Model Number
MWM4101
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K081635
Product Code
FRO
Product Code Name
Dressing, wound, drug
Public Device Record Key
7cca6b5b-c5d6-48a0-8f93-07b57788fcd9
Public Version Date
October 25, 2022
Public Version Number
7
DI Record Publish Date
September 23, 2015
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 75 |
| 3 | A medical device with high risk that requires premarket approval | 17 |
| U | Unclassified | 32 |