Duns Number:017415781
Device Description: Veritas® Collagen Matrix is an implantable biologic mesh comprised of noncrosslinked bovin Veritas® Collagen Matrix is an implantable biologic mesh comprised of noncrosslinked bovine pericardium. Veritas Collagen Matrix bovine pericardium is sourced from cattle less than 30 months of age.
Catalog Number
RM1212BIO
Brand Name
Veritas® Collagen Matrix
Version/Model Number
RM1212
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
-
Product Code
PAJ
Product Code Name
Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Public Device Record Key
195d1265-d0b6-4cca-8392-2e7ab440f6ca
Public Version Date
October 11, 2022
Public Version Number
4
DI Record Publish Date
October 05, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 135 |