| Primary Device ID | 18257200119325 |
| NIH Device Record Key | 0d2fa312-eae6-42ae-a12c-a44c817c7d6f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NAVIGATED INSTRUMENTS;FIREBIRD NXG |
| Version Model Number | 36-1345 |
| Company DUNS | 927083808 |
| Company Name | ORTHOFIX INC. |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 18257200119325 [Primary] |
| OLO | Orthopedic stereotaxic instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[18257200119325]
Moist Heat or Steam Sterilization
[18257200119325]
Moist Heat or Steam Sterilization
[18257200119325]
Moist Heat or Steam Sterilization
[18257200119325]
Moist Heat or Steam Sterilization
[18257200119325]
Moist Heat or Steam Sterilization
[18257200119325]
Moist Heat or Steam Sterilization
[18257200119325]
Moist Heat or Steam Sterilization
[18257200119325]
Moist Heat or Steam Sterilization
[18257200119325]
Moist Heat or Steam Sterilization
[18257200119325]
Moist Heat or Steam Sterilization
[18257200119325]
Moist Heat or Steam Sterilization
[18257200119325]
Moist Heat or Steam Sterilization
[18257200119325]
Moist Heat or Steam Sterilization
[18257200119325]
Moist Heat or Steam Sterilization
[18257200119325]
Moist Heat or Steam Sterilization
[18257200119325]
Moist Heat or Steam Sterilization
[18257200119325]
Moist Heat or Steam Sterilization
[18257200119325]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-27 |
| Device Publish Date | 2019-03-19 |
| 18257200121816 | AWL, NAVIGATED BL |
| 18257200121809 | AWL, NAVIGATED MDT |
| 18257200119820 | REDUCTION SCREW DRIVER, FIREBIRD NAVIGATED BL |
| 18257200119813 | REDUCTION SCREW DRIVER, FIREBIRD NAVIGATED MDT |
| 18257200119653 | MONOAXIAL SCREW DRIVER, FIREBIRD NAVIGATED, BL |
| 18257200119646 | MULTIAXIAL SCREW DRIVER, FIREBIRD NAVIGATED, BL |
| 18257200119639 | MODULAR SCREW DRIVER, FIREBIRD NAVIGATED BL |
| 18257200119622 | CANNULATED BONE TAP, 7.5MM, JANUS NAVIGATED BL |
| 18257200119615 | CANNULATED BONE TAP, 6.5MM, JANUS NAVIGATED BL |
| 18257200119608 | CANNULATED BONE TAP, 5.5MM, JANUS NAVIGATED BL |
| 18257200119592 | CANNULATED BONE TAP, 4.5MM, JANUS NAVIGATED, BL |
| 18257200119585 | BONE TAP, 7.5MM, JANUS NAVIGATED BL |
| 18257200119578 | BONE TAP, 6.5MM, JANUS NAVIGATED BL |
| 18257200119561 | BONE TAP, 5.5MM, JANUS NAVIGATED BL |
| 18257200119554 | BONE TAP, 4.5MM, JANUS NAVIGATED BL |
| 18257200119547 | BONE TAP, 8.5MM, FIREBIRD NAVIGATED BL |
| 18257200119530 | BONE TAP, 7.5MM, FIREBIRD NAVIGATED BL |
| 18257200119523 | BONE TAP, 6.5MM, FIREBIRD NAVIGATED BL |
| 18257200119516 | BONE TAP, 5.5MM, FIREBIRD NAVIGATED BL |
| 18257200119509 | BONE TAP, 4.5MM, FIREBIRD NAVIGATED BL |
| 18257200119493 | CANNULATED AWL, NAVIGATED BL |
| 18257200119486 | BONE PROBE, STRAIGHT THORACIC, NAVIGATED BL |
| 18257200119417 | MONOAXIAL SCREW DRIVER, FIREBIRD NAVIGATED MDT |
| 18257200119400 | MULTIAXIAL SCREW DRIVER, FIREBIRD NAVIGATED MDT |
| 18257200119394 | MODULAR SCREW DRIVER, FIREBIRD NAVIGATED MDT |
| 18257200119387 | CANNULATED BONE TAP, 7.5MM, JANUS NAVIGATED, MDT |
| 18257200119370 | CANNULATED BONE TAP, 6.5MM, JANUS NAVIGATED, MDT |
| 18257200119363 | CANNULATED BONE TAP, 5.5MM, JANUS NAVIGATED, MDT |
| 18257200119356 | CANNULATED BONE TAP, 4.5MM, JANUS NAVIGATED, MDT |
| 18257200119349 | BONE TAP, 7.5MM, JANUS NAVIGATED MDT |
| 18257200119332 | BONE TAP, 6.5MM, JANUS NAVIGATED MDT |
| 18257200119325 | BONE TAP, 5.5MM, JANUS NAVIGATED MDT |
| 18257200119318 | BONE TAP, 4.5MM, JANUS NAVIGATED MDT |
| 18257200119301 | BONE TAP, 8.5MM, FIREBIRD NAVIGATED MDT |
| 18257200119295 | BONE TAP, 7.5MM, FIREBIRD NAVIGATED MDT |
| 18257200119288 | BONE TAP, 6.5MM, FIREBIRD NAVIGATED MDT |
| 18257200119271 | BONE TAP, 5.5MM, FIREBIRD NAVIGATED MDT |
| 18257200119264 | BONE TAP, 4.5MM, FIREBIRD NAVIGATED MDT |
| 18257200119257 | CANNULATED AWL, NAVIGATED MDT |
| 18257200119240 | BONE PROBE, STRAIGHT THORACIC, NAVIGATED MDT |
| 18257200131365 | BONE PROBE, STRAIGHT DUCKBILL, NAVIGATED BL |
| 18257200131358 | BONE PROBE, STRAIGHT DUCKBILL, NAVIGATED MDT |