Duns Number:083171244
Device Description: Integra Wound Matrix and Integra Wound Matrix (Thin) are collagen-glycosaminoglycan wound Integra Wound Matrix and Integra Wound Matrix (Thin) are collagen-glycosaminoglycan wound dressings that maintain and support a healing environment for wound management. Integra Wound Matrix (Thin) has 50% less collagen compared to each of the corresponding sq cm sizes of Integra Wound Matrix.
Catalog Number
58101T
Brand Name
INTEGRA Wound Matrix (Thin)
Version/Model Number
58101T
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"
Yes
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
K113104
Product Code
KGN
Product Code Name
DRESSING, WOUND, COLLAGEN
Public Device Record Key
76c9c231-33d7-412b-856b-be56ce37d7b1
Public Version Date
September 22, 2020
Public Version Number
5
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 |