FlexFire Universal Cartridge OTOLoc Only FFU-CTG-5C

GUDID 00860012315543

The FlexFire Universal delivery tool consists of a handpiece and a distal cartridge. The Cartridge to allow for laparoscopic access to implant an OTOLoc contained in the cartridge. This architecture allows the user to reload a new Cartridge onto the Handpiece for the deployment of additional Implants as required by the surgical procedure. The user attaches the cartridge onto the Handpiece, inserts it through a trocar for use. After the implants has been fully deployed, the user can remove the FlexFire Universal Delivery Tool from the trocar and either reload it with another Cartridge for additional magnet implant deployments or discard it at the end of the procedure.

G.I. Windows, Inc.

Gastrointestinal anastomosis coupler, non-bioabsorbable

• Primary Device ID: 00860012315543
• NIH Device Record Key: fcf33f63-6ea4-4671-9187-67b530a49675
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FlexFire Universal Cartridge OTOLoc Only
• Version Model Number: 100028
• Catalog Number: FFU-CTG-5C
• Company DUNS: 077112264
• Company Name: G.I. Windows, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860012315543 [Primary]

FDA Product Code

• SAH: Magnetic Compression Anastomosis System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-04
• Device Publish Date: 2026-01-27

Devices Manufactured by G.I. Windows, Inc.

• 00860012315512 - FlexFire Universal Handpiece: 2026-02-04 The FlexFire Universal delivery tool consists of a handpiece and a distal cartridge. The Handpiece provides the user interface
• 00860012315529 - FlexFire Universal Cartridge - Flexagon( A) Plus OTOLoc: 2026-02-04 The FlexFire Universal delivery tool consists of a handpiece and a distal cartridge. The Cartridge to allow for laparoscopic ac
• 00860012315536 - FlexFire Universal Cartridge - Flexagon (B) Plus OTOLoc: 2026-02-04 The FlexFire Universal delivery tool consists of a handpiece and a distal cartridge. The Cartridge to allow for laparoscopic ac
• 00860012315543 - FlexFire Universal Cartridge OTOLoc Only: 2026-02-04The FlexFire Universal delivery tool consists of a handpiece and a distal cartridge. The Cartridge to allow for laparoscopic access to implant an OTOLoc contained in the cartridge. This architecture allows the user to reload a new Cartridge onto the Handpiece for the deployment of additional Implants as required by the surgical procedure. The user attaches the cartridge onto the Handpiece, inserts it through a trocar for use. After the implants has been fully deployed, the user can remove the FlexFire Universal Delivery Tool from the trocar and either reload it with another Cartridge for additional magnet implant deployments or discard it at the end of the procedure.
• 00860012315543 - FlexFire Universal Cartridge OTOLoc Only: 2026-02-04 The FlexFire Universal delivery tool consists of a handpiece and a distal cartridge. The Cartridge to allow for laparoscopic ac
• 00860012315550 - SNAP 2.0 Endoscopic Delivery Device: 2026-02-04 The SNAP 2.0 Endoscopic Delivery System comes pre-assembled with a Flexagon SFM magnet loaded inside it, with the SFM packed wi
• 00860012315505 - Titanium Grasper: 2024-08-15 The GI Windows Titanium Grasper is a surgical laparoscopic grasper with a non-ferrous distal actuator that is intended to be use