ProCol Biologic Vascular Graft

Basic Information

• Brand Name: ProCol Biologic Vascular Graft
• Primary DI: 00840663108688
• Version / Model: HJL016-40-N
• Catalog Number: HJL016-40-N
• Company Name: Lemaitre Vascular, Inc.
• Labeler DUNS: 184805166
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-03-22
• Public Version: 5
• Public Version Date: 2021-04-21
• Public Version Status: Update
• Public Device Record Key: d9632603-1d9f-4cd1-a398-9c4b73fb4255

Device Description

ProCol Biologic Vascular Graft, 6mm x 40 cm

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: 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
LXA	Tissue Graft Of 6mm And Greater	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
13586	Arteriovenous shunt	An implanted device designed to provide a passage for blood to flow between an artery typically located in an arm, and a peripheral vein, central vein or right atrium, creating a graft fistula that provides blood access for external procedures, especially haemodialysis. It is a synthetic vascular graft/graft assembly with a thin wall and appropriate size (commonly 6 mm diameter) and configuration to facilitate vessel puncturing. It is typically used when it is not possible or convenient to create a direct arteriovenous fistula or for patients who have exhausted peripheral venous access. Disposable devices associated with implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840663108688	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P020049	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 25 Degrees Celsius