FDA.reportPublic FDA data

FlexFire Universal Cartridge - Flexagon( A) Plus OTOLoc

Primary DI
00860012315529
Brand
FlexFire Universal Cartridge - Flexagon( A) Plus OTOLoc
Company
G.I. Windows, Inc.
Model
100026
Catalog number
FFU-CTG-5A
Device description
The FlexFire Universal delivery tool consists of a handpiece and a distal cartridge. The Cartridge to allow for laparoscopic access to implant the magnet (dipolar magnet A) and 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.
Published
2026-01-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
SAHMagnetic Compression Anastomosis System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SAHMagnetic Compression Anastomosis SystemGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860012315529PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860012315529008600123155298600123155290860012315529

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal anastomosis coupler, non-bioabsorbableAn implantable device intended to be used to join and transect excess tissue of gastrointestinal structures through the coupling of two ring-shaped components that are inserted into the ends of the segments to be attached. This device is made of a substance or material that cannot be chemically degraded or absorbed via natural body processes.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
077112264
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860012315505Titanium Grasper1000212024-08-07
00860012315512FlexFire Universal Handpiece 100016FFU-DLT-12026-01-27
00860012315536FlexFire Universal Cartridge - Flexagon (B) Plus OTOLoc 100027FFU-CTG-5B2026-01-27
00860012315543FlexFire Universal Cartridge OTOLoc Only 100028FFU-CTG-5C2026-01-27
00860012315550SNAP 2.0 Endoscopic Delivery Device100008SFM-25A-12026-01-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860012315512FlexFire Universal Handpiece G.I. Windows, Inc.SAH2026-01-27
00860012315536FlexFire Universal Cartridge - Flexagon (B) Plus OTOLoc G.I. Windows, Inc.SAH2026-01-27
00860012315543FlexFire Universal Cartridge OTOLoc Only G.I. Windows, Inc.SAH2026-01-27
00860012315550SNAP 2.0 Endoscopic Delivery DeviceG.I. Windows, Inc.SAH2026-01-27
00850054216113GT Metabolic DI Magnet - 50mmGt Metabolic Solutions, Inc.SAH2025-03-14
00850054216052GT Metabolic Delivery SystemGt Metabolic Solutions, Inc.SAH2024-12-13
00850054216069GT Metabolic DI Magnet - 40mmGt Metabolic Solutions, Inc.SAH2024-12-13