| Primary Device ID | 00860012315505 |
| NIH Device Record Key | 58a90732-10d2-496b-91ca-8c2234f25bb6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Titanium Grasper |
| Version Model Number | 200123 |
| Company DUNS | 077112264 |
| Company Name | G.I. Windows, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860012315505 [Primary] |
| GEN | Forceps, General & Plastic Surgery |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00860012315505]
Dry Heat Sterilization
[00860012315505]
Dry Heat Sterilization
[00860012315505]
Dry Heat Sterilization
[00860012315505]
Dry Heat Sterilization
[00860012315505]
Dry Heat Sterilization
[00860012315505]
Dry Heat Sterilization
[00860012315505]
Dry Heat Sterilization
[00860012315505]
Dry Heat Sterilization
[00860012315505]
Dry Heat Sterilization
[00860012315505]
Dry Heat Sterilization
[00860012315505]
Dry Heat Sterilization
[00860012315505]
Dry Heat Sterilization
[00860012315505]
Dry Heat Sterilization
[00860012315505]
Dry Heat Sterilization
[00860012315505]
Dry Heat Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-15 |
| Device Publish Date | 2024-08-07 |
| 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 | 2026-02-04 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 | 2024-08-15The 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. |
| 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 |