| Primary Device ID | 07899258695082 |
| NIH Device Record Key | bbece8f3-e842-4f0d-bc4f-e59b23759542 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GMReis Fibula Nail System |
| Version Model Number | Left Fibula Nail 3,6x145mm |
| Catalog Number | 302-05US |
| Company DUNS | 900865213 |
| Company Name | GM DOS REIS INDUSTRIA E COMERCIO LTDA |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07899258695082 [Primary] |
| HSB | Rod, Fixation, Intramedullary And Accessories |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07899258695082]
Moist Heat or Steam Sterilization
[07899258695082]
Moist Heat or Steam Sterilization
[07899258695082]
Moist Heat or Steam Sterilization
[07899258695082]
Moist Heat or Steam Sterilization
[07899258695082]
Moist Heat or Steam Sterilization
[07899258695082]
Moist Heat or Steam Sterilization
[07899258695082]
Moist Heat or Steam Sterilization
[07899258695082]
Moist Heat or Steam Sterilization
[07899258695082]
Moist Heat or Steam Sterilization
[07899258695082]
Moist Heat or Steam Sterilization
[07899258695082]
Moist Heat or Steam Sterilization
[07899258695082]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-12-08 |
| Device Publish Date | 2025-06-24 |
| 07899258695044 | Left Fibula Nail 3,0x110mm |
| 07899258695150 | Right Fibula Nail 3,6x180mm |
| 07899258695143 | Right Fibula Nail 3,6x145mm |
| 07899258695136 | Right Fibula Nail 3,6x110mm |
| 07899258695129 | Right Fibula Nail 3,0x180mm |
| 07899258695112 | Right Fibula Nail 3,0x145mm |
| 07899258695105 | Right Fibula Nail 3,0x110mm |
| 07899258695099 | Left Fibula Nail 3,6x180mm |
| 07899258695082 | Left Fibula Nail 3,6x145mm |
| 07899258695075 | Left Fibula Nail 3,6x110mm |
| 07899258695068 | Left Fibula Nail3,0x180mm |
| 07899258695051 | Left Fibula Nail 3,0x145mm |
| 07899258695037 | Locking Screw T10 Ø3,5mm X 65,0mm |
| 07899258695020 | Locking Screw T10 Ø3,5mm X 60,0mm |
| 07899258695013 | Locking Screw T10 Ø3,5mm X 55,0mm |
| 07899258695006 | Locking Screw T10 Ø3,5mm X 50,0mm |
| 07899258694993 | Locking Screw T10 Ø3,5mm X 45,0mm |
| 07899258694986 | Locking Screw T10 Ø3,5mm X 40,0mm |
| 07899258694979 | Locking Screw T10 Ø3,5mm X 35,0mm |
| 07899258694962 | Locking Screw T10 Ø3,5mm X 30,0mm |
| 07899258694955 | Locking Screw T10 Ø3,5mm X 25,0mm |
| 07899258694948 | Locking Screw T10 Ø3,5mm X 22,0mm |
| 07899258694931 | Locking Screw T10 Ø3,5mm X 20,0mm |
| 07899258694924 | Locking Screw T10 Ø3,5mm X 18,0mm |
| 07899258694917 | Locking Screw T10 Ø3,5mm X 16,0mm |
| 07899258694900 | Locking Screw T10 Ø3,5mm X 14,0mm |
| 07899258694894 | Locking Screw T10 Ø3,5mm X 12,0mm |
| 07899258694887 | Locking Screw T10 Ø3,5mm X 10,0mm |
| 07899258694870 | Locking Screw T10 Ø3,5mm X 8,0mm |