FlexFire Universal Handpiece
Basic Information
- Brand Name
- FlexFire Universal Handpiece
- Primary DI
- 00860012315512
- Version / Model
- 100016
- Catalog Number
- FFU-DLT-1
- Company Name
- G.I. Windows, Inc.
- Labeler DUNS
- 077112264
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-27
- Public Version
- 1
- Public Version Date
- 2026-02-04
- Public Version Status
- New
- Public Device Record Key
- 75d37577-53f3-4713-8872-b6bd5a54c35e
Device Description
The FlexFire Universal delivery tool consists of a handpiece and a distal cartridge. The Handpiece provides the user interface and a shaft member that receives and mates with the Cartridge to allow for laparoscopic access to implant the magnet 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 procecdure. 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.
Device Characteristics
- Single Use
- Yes
- 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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| SAH | Magnetic Compression Anastomosis System | General, Plastic Surgery | 878.4816 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 18135 | Gastrointestinal anastomosis coupler, non-bioabsorbable | An 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. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860012315512 | GS1 |