Veritas® Collagen Matrix

Basic Information

• Brand Name: Veritas® Collagen Matrix
• Primary DI: 00085412531236
• Version / Model: RM1016
• Catalog Number: RM1016BIO
• Company Name: SYNOVIS LIFE TECHNOLOGIES, INC.
• Labeler DUNS: 017415781
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-05
• Public Version: 6
• Public Version Date: 2023-10-04
• Public Version Status: Update
• Public Device Record Key: 35bf3879-1d07-4867-997a-0f10393a5e47

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PAJ	Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed	General, Plastic Surgery	878.3300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00085412531236	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at a controlled room temperature. Keep away from heat. Do not use if heat indicator is red.
• Type: Storage Environment Temperature
• Temperature Range: 68 – 77 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius