TILink-P Graft Pusher Dilator

Basic Information

• Brand Name: TILink-P Graft Pusher Dilator
• Primary DI: 00810131880521
• Version / Model: SR16-3901
• Company Name: SURGENTEC, LLC
• Labeler DUNS: 004095409
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-16
• Public Version: 3
• Public Version Date: 2026-02-03
• Public Version Status: Update
• Public Device Record Key: 7f6485e9-2fb5-4b1d-999a-a9088f760015

Device Characteristics

• Single Use: No
• 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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OUR	Sacroiliac Joint Fixation	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58733	Sacroiliac joint intra-articular arthrodesis implant	An implantable device designed to achieve and maintain the distraction of degenerated articular surfaces of the sacroiliac joint to assist in intra- and extra-articular bone grafting and fusion (arthrodesis), typically performed to alleviate pain from the sacroiliac joints in skeletally mature patients. The device is a tapered tube made of titanium alloy which has radial fenestrations to encourage bony in-growth. It is surgically implanted under fluoroscopic guidance using an assortment of dedicated tools. It is available in several sizes and intended for permanent implantation.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810131880521	GS1