| Primary Device ID | 18054242511458 |
| NIH Device Record Key | 25df6418-d90b-413f-9f94-5f7bab4144bc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ankle Compression Nailing System |
| Version Model Number | 1 |
| Catalog Number | 99-T775060 |
| Company DUNS | 438793622 |
| Company Name | ORTHOFIX SRL |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | true |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +039456719000 |
| info@orthofix.it | |
| Phone | +039456719000 |
| info@orthofix.it | |
| Phone | +039456719000 |
| info@orthofix.it | |
| Phone | +039456719000 |
| info@orthofix.it | |
| Phone | +039456719000 |
| info@orthofix.it | |
| Phone | +039456719000 |
| info@orthofix.it | |
| Phone | +039456719000 |
| info@orthofix.it | |
| Phone | +039456719000 |
| info@orthofix.it | |
| Phone | +039456719000 |
| info@orthofix.it | |
| Phone | +039456719000 |
| info@orthofix.it | |
| Phone | +039456719000 |
| info@orthofix.it | |
| Phone | +039456719000 |
| info@orthofix.it | |
| Phone | +039456719000 |
| info@orthofix.it | |
| Phone | +039456719000 |
| info@orthofix.it | |
| Phone | +039456719000 |
| info@orthofix.it |
| Outer Diameter | 5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 60 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 18054242511458 [Primary] |
| HSB | Rod, Fixation, Intramedullary And Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2015-09-01 |
| 18054242512981 | TITANIUM ANKLE HINDFOOT NAIL 12/300 |
| 18054242512974 | TITANIUM ANKLE HINDFOOT NAIL 12/250 |
| 18054242512967 | TITANIUM ANKLE HANDFOOT NAIL 12/200 |
| 18054242512950 | TITANIUM ANKLE HINDFOOT NAIL 12/150 |
| 18054242512943 | TITANIUM ANKLE HINDFOOT NAIL 11/300 |
| 18054242512936 | TITANIUM ANKLE HINDFOOT NAIL 11/250 |
| 18054242512929 | SHORT RETROGRADE NAIL STERILE DIAMETER 11 MM LENGTH 200 MM |
| 18054242512912 | TITANIUM ANKLE HINDFOOT NAIL 11/150 |
| 18054242512905 | TITANIUM ANKLE HINDFOOT NAIL 10/300 |
| 18054242512899 | TITANIUM ANKLE HINDFOOT NAIL 10/250 |
| 18054242512882 | TITANIUM ANKLE HINDFOOT NAIL 10/200 |
| 18054242512875 | TITANIUM ANKLE HINDFOOT NAIL 10/150 |
| 18054242512868 | ANKLE HINDFOOT NAILING SYSTEM - DRILLS AND REAMERS CASE EMPTY |
| 18054242512851 | ANKLE HINDFOOT NAILING SYSTEM - INSERTION INSTRUMENTS CASE EMPTY |
| 18054242512844 | ANKLE HINDFOOT NAILING SYSTEM - EXTRACTION INSTRUMENTS CASE EMPTY |
| 18054242512837 | CROSS-THREADING ADAPTOR |
| 18054242512820 | SLAP HAMMER ADAPTOR |
| 18054242512813 | NEEDLE NOSE VISE GRIPS |
| 18054242512806 | SCREW HEAD GOUGE |
| 18054242512790 | SCREW EXTRACTOR, SIZE 5 |
| 18054242512783 | SCREW EXTRACTOR, SIZE 4 |
| 18054242512271 | TITANIUM LOW PROFILE SCREW, D 5MM L 37.5MM |
| 18054242512264 | TITANIUM LOW PROFILE SCREW, D 5MM L 32.5MM |
| 18054242511571 | TITANIUM LOW PROFILE SCREW, D 5MM L 27.5MM |
| 18054242511564 | TITANIUM LOW PROFILE SCREW, D 5MM L 22.5MM |
| 18054242511458 | TITANIUM CALCANEUS THREADED HEAD SCREW D 5MM L 60MM |
| 18054242511441 | TITANIUM CALCANEUS THREADED HEAD SCREW D 5MM L 65MM |
| 18054242510154 | PLASTIC INSERT FOR SLOTTED MALLET |
| 18033509859175 | 1.8 X 350MM GUIDE-WIRE |
| 18033509859168 | ANKLE COMPRESSION DRILLS AND REAMERS TRAY EMPTY |
| 18033509859151 | ANKLE COMPRESSION INSERTION INSTRUMENTS TRAY EMPTY |
| 18033509859144 | LOCKING CAM |
| 18033509859137 | COUNTERSINK |
| 18033509859120 | LOCKING END CAP 10 MM |
| 18033509859113 | LOCKING END CAP 5 MM |
| 18033509859106 | LOCKING END CAP 0 MM |
| 18033509859090 | SHORT DEPTH GAUGE |
| 18033509859083 | 4.3MM FREEHAND DRILL |
| 18033509859076 | 24MM WRENCH |
| 18033509859069 | LONG DEPTH GAUGE |
| 18033509859052 | LOCKING DRIVER |
| 18033509859045 | COMPRESSION DRIVER |
| 18033509859038 | 3.5MM HEX SCREW DRIVER |
| 18033509859021 | RATCHETING STRAIGHT HANDLE |
| 18033509859014 | RATCHETING T-HANDLE |
| 18033509859007 | 6.1MM DRILL FOR THREADED HEAD SCREW |
| 18033509858994 | 4.3MM CALIBRATED DRILL |
| 18033509858987 | TROCAR |
| 18033509858970 | 4.3MM DRILL GUIDE |
| 18033509858963 | SCREW GUIDE |