| Primary Device ID | 08800039801829 |
| NIH Device Record Key | 6de702da-d949-4e0a-b9b4-c218d9501238 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fortis ACP |
| Version Model Number | A |
| Catalog Number | TP.FT.4010 |
| Company DUNS | 557795909 |
| Company Name | DIOMEDICAL CO.,LTD. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 |
| Phone | +82313699470 |
| info@huvexel.com | |
| Phone | +82313699470 |
| info@huvexel.com | |
| Phone | +82313699470 |
| info@huvexel.com | |
| Phone | +82313699470 |
| info@huvexel.com | |
| Phone | +82313699470 |
| info@huvexel.com | |
| Phone | +82313699470 |
| info@huvexel.com | |
| Phone | +82313699470 |
| info@huvexel.com | |
| Phone | +82313699470 |
| info@huvexel.com | |
| Phone | +82313699470 |
| info@huvexel.com | |
| Phone | +82313699470 |
| info@huvexel.com | |
| Phone | +82313699470 |
| info@huvexel.com | |
| Phone | +82313699470 |
| info@huvexel.com | |
| Phone | +82313699470 |
| info@huvexel.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800039801829 [Primary] |
| KWQ | Appliance, fixation, spinal intervertebral body |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800039801829]
Moist Heat or Steam Sterilization
[08800039801829]
Moist Heat or Steam Sterilization
[08800039801829]
Moist Heat or Steam Sterilization
[08800039801829]
Moist Heat or Steam Sterilization
[08800039801829]
Moist Heat or Steam Sterilization
[08800039801829]
Moist Heat or Steam Sterilization
[08800039801829]
Moist Heat or Steam Sterilization
[08800039801829]
Moist Heat or Steam Sterilization
[08800039801829]
Moist Heat or Steam Sterilization
[08800039801829]
Moist Heat or Steam Sterilization
[08800039801829]
Moist Heat or Steam Sterilization
[08800039801829]
Moist Heat or Steam Sterilization
[08800039801829]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-09-18 |
| Device Publish Date | 2019-02-08 |
| 08800039802048 | Pre-set angle Drill Guide (single barrel) - like Uniplate |
| 08800039802031 | Variable angle Drill Guide (single barrel) - like Uniplate |
| 08800039802017 | Plate Holder |
| 08800039870474 | FORTIS 2.36mm Longer HEX Screwdriver |
| 08800039868334 | Fortis Temporary Fixation pin Long type |
| 08800039834490 | Fixed Angle Selftapping Rounded Screw 4.5 X 26 |
| 08800039834483 | Fixed Angle Selftapping Rounded Screw 4.5 X 24 |
| 08800039834469 | Fixed Angle Selftapping Rounded Screw 4.5 X 20 |
| 08800039834452 | Fixed Angle Selftapping Rounded Screw 4.5 X 18 |
| 08800039834445 | Fixed Angle Selftapping Rounded Screw 4.5 X 16 |
| 08800039834438 | Fixed Angle Selftapping Rounded Screw 4.5 X 14 |
| 08800039834421 | Fixed Angle Selftapping Rounded Screw 4.5 X 12 |
| 08800039834414 | Fixed Angle Selftapping Rounded Screw 4.5 X 10 |
| 08800039834407 | Fixed Angle Selftapping Rounded Screw 4.0 X 26 |
| 08800039834391 | Fixed Angle Selftapping Rounded Screw 4.0 X 24 |
| 08800039834384 | Fixed Angle Selftapping Rounded Screw 4.0 X 22 |
| 08800039834377 | Fixed Angle Selftapping Rounded Screw 4.0 X 20 |
| 08800039834360 | Fixed Angle Selftapping Rounded Screw 4.0 X 18 |
| 08800039834353 | Fixed Angle Selftapping Rounded Screw 4.0 X 16 |
| 08800039834346 | Fixed Angle Selftapping Rounded Screw 4.0 X 14 |
| 08800039834339 | Fixed Angle Selftapping Rounded Screw 4.0 X 12 |
| 08800039834322 | Fixed Angle Selftapping Rounded Screw 4.0 X 10 |
| 08800039834315 | Variable Angle Selftapping Rounded Screw 4.5 X 26 |
| 08800039834308 | Variable Angle Selftapping Rounded Screw 4.5 X 24 |
| 08800039834292 | Variable Angle Selftapping Rounded Screw 4.5 X 22 |
| 08800039834285 | Variable Angle Selftapping Rounded Screw 4.5 X 20 |
| 08800039834278 | Variable Angle Selftapping Rounded Screw 4.5 X 18 |
| 08800039834261 | Variable Angle Selftapping Rounded Screw 4.5 X 16 |
| 08800039834254 | Variable Angle Selftapping Rounded Screw 4.5 X 14 |
| 08800039834247 | Variable Angle Selftapping Rounded Screw 4.5 X 12 |
| 08800039834230 | Variable Angle Selftapping Rounded Screw 4.5 X 10 |
| 08800039834223 | Variable Angle Selftapping Rounded Screw 4.0 X 26 |
| 08800039834216 | Variable Angle Selftapping Rounded Screw 4.0 X 24 |
| 08800039834209 | Variable Angle Selftapping Rounded Screw 4.0 X 22 |
| 08800039834193 | Variable Angle Selftapping Rounded Screw 4.0 X 20 |
| 08800039834186 | Variable Angle Selftapping Rounded Screw 4.0 X 18 |
| 08800039834179 | Variable Angle Selftapping Rounded Screw 4.0 X 16 |
| 08800039834162 | Variable Angle Selftapping Rounded Screw 4.0 X 14 |
| 08800039834155 | Variable Angle Selftapping Rounded Screw 4.0 X 12 |
| 08800039834148 | Variable Angle Selftapping Rounded Screw 4.0 X 10 |
| 08800039830935 | EXTENDED FORTIS DRILL |
| 08800039830928 | EXTENDED FORTIS DRILL |
| 08800039830911 | EXTENDED FORTIS DRILL |
| 08800039830904 | EXTENDED FORTIS DRILL |
| 08800039830898 | EXTENDED FORTIS AWL |
| 08800039830553 | Fortis self Ramp driver |
| 08800039830546 | Tapered Fortis self retaining driver |
| 08800039829977 | DRIVING HANDLE SHORT A-O TYPE |
| 08800039825535 | 2.38mm HEX DRIVER SHORT TYPE |
| 08800039825528 | SCREW DRIVER 2.3mm HEX ONE BODY |