Duns Number:083171244
Device Description: INTEGRA Flowable Wound Matrix is an advanced wound care device comprised of granulated cro INTEGRA Flowable Wound Matrix is an advanced wound care device comprised of granulated cross-linked bovine tendon collagen and glycosaminoglycan. The granulated collagen-glycosaminoglycan is hydrated with saline and applied in difficult to access wound sites and tunneled wounds. It provides a scaffold for cellular invasion and cappilary growth. INTEGRA Flowable Wound Matrix is supplied sterile, in single use kits containing one syringe with granular collagen, one empty sterile syringe, one luer lock connector, and one flexible injector.
Catalog Number
FWD301
Brand Name
INTEGRA Flowable Wound Matrix
Version/Model Number
FWD301
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
K072113
Product Code
KGN
Product Code Name
DRESSING, WOUND, COLLAGEN
Public Device Record Key
94f2b815-3ff5-4a2f-9f6d-ca7ff4abc8ce
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 |