Titanium Grasper

Basic Information

• Brand Name: Titanium Grasper
• Primary DI: 00860012315505
• Version / Model: 200123
• Company Name: G.I. Windows, Inc.
• Labeler DUNS: 077112264
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-07
• Public Version: 1
• Public Version Date: 2024-08-15
• Public Version Status: New
• Public Device Record Key: 58a90732-10d2-496b-91ca-8c2234f25bb6

Device Description

The GI Windows Titanium Grasper is a surgical laparoscopic grasper with a non-ferrous distal actuator that is intended to be used with GIW’s Self-Forming Magnet (SFM) technology. The grasper’s form factor, handle, length, and actuation will be nearly identical to commercially available laparoscopic graspers that we used every day in the operating room. The primary differentiator of this product will be the titanium distal actuator, which due to its non-ferrous make up, will not create (or minimally create) a magnetic attraction force to the SFM implants while in use in surgery.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• 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: Dry Heat Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62468	Surgical soft-tissue manipulation forceps, scissors-like, reusable	A hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860012315505	GS1