Duns Number:023369802
Device Description: The Fibralign BioBridge® Collagen Matrix is a sterile, thin collagen ribbon made of highly The Fibralign BioBridge® Collagen Matrix is a sterile, thin collagen ribbon made of highly purified pepsin treated Type 1 porcine collagen and features Fibralign’s Nanoweave® technology. It is provided in single use packaging with five devices included in each package.
Catalog Number
PRT0070
Brand Name
BioBridge® Collagen Matrix
Version/Model Number
PRT0070
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K151083,K151083
Product Code
OWY
Product Code Name
Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
Public Device Record Key
60531ffa-b7fc-493c-8162-42da544b9933
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
December 30, 2020
Package DI Number
B218PRT00700
Quantity per Package
1
Contains DI Package
B218PRT0070
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Tyvek