JRF VersaGraft 3.5

Basic Information

• Brand Name: JRF VersaGraft 3.5
• Primary DI: 00860424000242
• Version / Model: 1
• Catalog Number: VRG-351
• Company Name: JOINT RESTORATION FOUNDATION INC
• Labeler DUNS: 791391233
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-18
• Public Version: 1
• Public Version Date: 2018-10-19
• Public Version Status: New
• Public Device Record Key: 14bb22d1-b5b2-4efb-b87a-72f64a396332

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: Yes
• 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: Yes
• 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
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	878.5000	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60501	Tendon graft	A sterile tendon tissue, which may include a bone block, intended for transplantation that is harvested from a human donor. The tissue is intended to be used to replace or strengthen damaged tendon in any part of the human body. It may include non-tissue components (e.g. suture) to facilitate its implantation or function. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860424000242	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -80 – -40 Degrees Celsius