Home GUDID 00860012315505
Titanium Grasper
Primary DI 00860012315505
Brand Titanium Grasper
Company G.I. Windows, Inc.
Model 100021
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.
Published 2024-08-07
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
OTC true Product Codes# Code, Name table Code Name GEN Forceps, General & Plastic Surgery
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GEN Forceps, General & Plastic Surgery General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860012315505 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00860012315505 00860012315505 860012315505 0860012315505
GMDN Terms# Term, Definition table Term Definition 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.
Sterilization Methods# Method table Method Dry Heat Sterilization
Regulatory Flags# DUNS number 077112264 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00860012315512 FlexFire Universal Handpiece 100016 FFU-DLT-1 2026-01-27 00860012315529 FlexFire Universal Cartridge - Flexagon( A) Plus OTOLoc 100026 FFU-CTG-5A 2026-01-27 00860012315536 FlexFire Universal Cartridge - Flexagon (B) Plus OTOLoc 100027 FFU-CTG-5B 2026-01-27 00860012315543 FlexFire Universal Cartridge OTOLoc Only 100028 FFU-CTG-5C 2026-01-27 00860012315550 SNAP 2.0 Endoscopic Delivery Device 100008 SFM-25A-1 2026-01-27
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00850083275075 Intrace USA PILOTIS TECH LLC GEN 2026-07-03 00850083275082 Intrace USA PILOTIS TECH LLC GEN 2026-07-03 00850083275099 Intrace USA PILOTIS TECH LLC GEN 2026-07-03 00850083275105 Intrace USA PILOTIS TECH LLC GEN 2026-07-03 00850083275112 Intrace USA PILOTIS TECH LLC GEN 2026-07-03 00850083275129 Intrace USA PILOTIS TECH LLC GEN 2026-07-03 00850083275136 Intrace USA PILOTIS TECH LLC GEN 2026-07-03 00850083275143 Intrace USA PILOTIS TECH LLC GEN 2026-07-03 00850083275280 Intrace USA PILOTIS TECH LLC GEN 2026-07-03 00850083275310 Intrace USA PILOTIS TECH LLC GEN 2026-07-03 00850083275334 Intrace USA PILOTIS TECH LLC GEN 2026-07-03 00850083275358 Intrace USA PILOTIS TECH LLC GEN 2026-07-03 00850083275440 Intrace USA PILOTIS TECH LLC GEN 2026-07-03 00850083275471 Intrace USA PILOTIS TECH LLC GEN 2026-07-03 00850083275495 Intrace USA PILOTIS TECH LLC GEN 2026-07-03 00850083275600 Intrace USA PILOTIS TECH LLC GEN 2026-07-03 00850083275723 Intrace USA PILOTIS TECH LLC GEN 2026-07-03 00850083275846 Intrace USA PILOTIS TECH LLC GEN 2026-07-03 00850083275938 Intrace USA PILOTIS TECH LLC GEN 2026-07-03 00850083275976 Intrace USA PILOTIS TECH LLC GEN 2026-07-03 00860015282088 Intrace USA PILOTIS TECH LLC GEN 2026-07-03 00190776421656 Millennium Avalign Technologies, Inc. GEN 2026-06-23 00810055258512 Surgical Design Surgical Design, Inc. GEN 2026-06-22 00810055258543 Surgical Design Surgical Design, Inc. GEN 2026-06-22 00810055258550 Surgical Design Surgical Design, Inc. GEN 2026-06-22 00810055258567 Surgical Design Surgical Design, Inc. GEN 2026-06-22 00810055258574 Surgical Design Surgical Design, Inc. GEN 2026-06-22 05060212051196 Adson Non-Toothed Forceps 120mm DTR MEDICAL LIMITED GEN 2026-06-10 05060212051202 Adson Toothed Forceps 120mm DTR MEDICAL LIMITED GEN 2026-06-10 05060411980822 Allis Tissue Forceps, 3:4 teeth, 160mm DTR MEDICAL LIMITED GEN 2026-06-10