| Primary Device ID | 18056099649759 |
| NIH Device Record Key | 1e962594-7441-48cc-966c-54d06eb6425e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OSCAR 3 |
| Version Model Number | 1 |
| Catalog Number | OBE2000 |
| 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 | 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 | true |
| OTC Over-The-Counter | false |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 18056099649759 [Primary] |
| LZV | System, Cement Removal Extraction |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[18056099649759]
Moist Heat or Steam Sterilization
[18056099649759]
Moist Heat or Steam Sterilization
[18056099649759]
Moist Heat or Steam Sterilization
[18056099649759]
Moist Heat or Steam Sterilization
[18056099649759]
Moist Heat or Steam Sterilization
[18056099649759]
Moist Heat or Steam Sterilization
[18056099649759]
Moist Heat or Steam Sterilization
[18056099649759]
Moist Heat or Steam Sterilization
[18056099649759]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-24 |
| Device Publish Date | 2017-09-18 |
| 18056099649995 | BONECUTTER OSTEOTOME HANDSET |
| 18056099649988 | CEMENT REMOVAL HANDSET |
| 18056099649971 | ULTRASONIC GENERATOR 230V CE |
| 18056099649964 | LONG EXTENSION REDUCER BAR FOR SINGLE USE PROBES |
| 18056099649957 | SHORT EXTENSION REDUCER BAR FOR SINGLE USE PROBES |
| 18056099649940 | SINGLE USE LONG EXTENSION REDUCER BAR – STERILE |
| 18056099649933 | SINGLE USE SHORT EXTENSION REDUCER BAR – STERILE |
| 18056099649926 | SINGLE USE 2 LOBED GROOVER PROBE – STERILE |
| 18056099649919 | SINGLE USE FLAT PIERCER PROBE – STERILE |
| 18056099649902 | REDUCER BAR FOR OHP218FSU |
| 18056099649896 | SINGLE USE 8MM HOE PROBE – STERILE |
| 18056099649889 | SINGLE USE 6MM HOE PROBE - 180MM – STERILE |
| 18056099649872 | SINGLE USE 6MM SERRATED CURVED OSTEOTOME – STERILE |
| 18056099649865 | SINGLE USE 6MM FLAT OSTEOTOME – STERILE |
| 18056099649858 | SINGLE USE 6MM SERRATED OSTEOTOME – STERILE |
| 18056099649841 | SINGLE USE ACETABULAR PROBE – STERILE |
| 18056099649834 | SINGLE USE EXTRACTION PROBE FOR SLAPHAMMER – STERILE |
| 18056099649827 | SLAPHAMMER (CONSUMABLE) |
| 18056099649810 | SINGLE USE 6MM SCRAPER PROBE - SLIM - 180MM – STERILE |
| 18056099649803 | SINGLE USE 6MM PIERCER PROBE - SLIM - 180MM – STERILE |
| 18056099649797 | SINGLE USE 10MM SCRAPER PROBE - 80MM – STERILE |
| 18056099649780 | SINGLE USE 8MM SCRAPER PROBE - 80MM – STERILE |
| 18056099649773 | SINGLE USE 10MM PIERCER PROBE – STERILE |
| 18056099649766 | SINGLE USE 8MM PIERCER PROBE – STERILE |
| 18056099649759 | BONECUTTER - EXTENSION BAR |
| 18056099649742 | EXTENSION BAR |
| 18056099649735 | ACETABULAR PROBE |
| 18056099649728 | 13MM PIERCER PROBE - 180MM |
| 18056099649711 | 11MM PIERCER PROBE - 175MM |
| 18056099649704 | 10MM PIERCER PROBE - 175MM |
| 18056099649698 | 8MM PIERCER PROBE - 180MM |
| 18056099649681 | 6MM PIERCER PROBE - 180MM |
| 18056099648660 | 10MM SCRAPER PROBE - 90MM |
| 18056099648653 | 8MM SCRAPER PROBE - 180MM |
| 18056099648646 | 6MM SCRAPER PROBE - 180MM |
| 18056099648639 | GROOVER PROBE - 2 LOBE - 90MM |
| 18056099648622 | EXTRACTION PROBE FOR SLAPHAMMER |
| 18053504360148 | ULTRASONIC GENERATOR 115V UL |
| 18053504360131 | SPANNER 8/9MM |
| 18053504360124 | SPANNER 7MM |
| 18053504360117 | OSCAR 3 INSTRUMENTS SINGLE USE |
| 18053504360100 | OSCAR 3 INSTRUMENTS REUSABLE |
| 18053504360094 | OSCAR 3 GENERATOR |
| 18053504360087 | OSCAR 2 INSTRUMENTS SINGLE USE |
| 18053504360070 | OSCAR 2 INSTRUMENTS REUSABLE |
| 18053504360056 | EXTENSION REDUCER BAR |
| 18053504360049 | EXTENSION REDUCER BAR |
| 18053504360032 | 8MM PIERCER CURVED |
| 18053504360025 | OSCAR STERILIZATION TRAY |
| 18053504360018 | FOOTSWITCH |