AccessGUDID - DEVICE: BioBridge® Collagen Matrix (B218PRT0070)

GUDID

Device Identifier (DI) Information

Brand Name: BioBridge® Collagen Matrix
Version or Model: PRT0070
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PRT0070
Company Name: Fibralign Corporation

Primary DI Number: B218PRT0070
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 023369802 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60907	Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial	A bioabsorbable, implantable material (e.g., flat sheet) made from animal-derived collagen intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]; some types may also be intended for use as a short-term scaffold for tissue regeneration. It is constructed of collagen, which might be cross-linked (e.g., with glutaraldehyde); it does not include antimicrobial agents/materials. Disposable devices associated with implantation may be supplied with the mesh.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
OWY	Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K151083	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep Dry
Storage Environment Temperature: less than 37 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 60531ffa-b7fc-493c-8162-42da544b9933
Public Version Date: October 04, 2023
Public Version Number: 5
DI Record Publish Date: December 30, 2020