| Primary Device ID | 18257200080144 |
| NIH Device Record Key | b909cbee-2b1e-434f-9b6e-59e2a689697f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PHOENIX SFS |
| Version Model Number | 20-0332 |
| Company DUNS | 927083808 |
| Company Name | ORTHOFIX INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 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 | 18257200080144 [Primary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[18257200080144]
Moist Heat or Steam Sterilization
[18257200080144]
Moist Heat or Steam Sterilization
[18257200080144]
Moist Heat or Steam Sterilization
[18257200080144]
Moist Heat or Steam Sterilization
[18257200080144]
Moist Heat or Steam Sterilization
[18257200080144]
Moist Heat or Steam Sterilization
[18257200080144]
Moist Heat or Steam Sterilization
[18257200080144]
Moist Heat or Steam Sterilization
[18257200080144]
Moist Heat or Steam Sterilization
[18257200080144]
Moist Heat or Steam Sterilization
[18257200080144]
Moist Heat or Steam Sterilization
[18257200080144]
Moist Heat or Steam Sterilization
[18257200080144]
Moist Heat or Steam Sterilization
[18257200080144]
Moist Heat or Steam Sterilization
[18257200080144]
Moist Heat or Steam Sterilization
[18257200080144]
Moist Heat or Steam Sterilization
[18257200080144]
Moist Heat or Steam Sterilization
[18257200080144]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-20 |
| Device Publish Date | 2019-03-12 |
| 18257200134434 | 9.5MM CANULATED JANUS TAP |
| 18257200134427 | 8.5MM CANULATED JANUS TAP |
| 18257200134410 | 7.5MM CANULATED JANUS TAP |
| 18257200134403 | 6.5MM CANULATED JANUS TAP |
| 18257200134397 | 5.5MM CANULATED JANUS TAP |
| 18257200134380 | 4.5MM CANULATED JANUS TAP |
| 18257200133574 | GUIDE WIRE, NITINOL, 21", SHARP, THREADED |
| 18257200125814 | BONE MARROW ASPIRATION NEEDLE, 11 GAGE, 8" LENGTH |
| 18257200125784 | BONE MARROW ASPIRATION NEEDLE, 8 GAGE, 6" LENGTH |
| 18257200117505 | LID, PHOENIX, IMPLANT CASE |
| 18257200117499 | BOTTOM TRAY, PHOENIX, IMPLANT CASE |
| 18257200117482 | BASE, PHOENIX, IMPLANT CASE |
| 18257200117475 | LID, PHOENIX, INSTRUMENT CASE 2 |
| 18257200117468 | BASE, PHOENIX, INSTRUMENT CASE 2 |
| 18257200117451 | SCREW BODY CADDY 2ND TRAY, STD/SHORT, PHOENIX, IMPLANT CASE |
| 18257200117086 | SET SCREW CADDY, PHOENIX, IMPLANT CASE |
| 18257200117079 | GUIDE WIRE, SHARP, PHOENIX, INSTRUMENT CASE |
| 18257200117062 | GUIDEWIRE, BLUNT, PHOENIX, INSTRUMENT CASE |
| 18257200117055 | 90-7337, SCREW BODY CADDY, TALL, PHOENIX, IMPLANT CASE |
| 18257200117048 | SCREW BODY CADDY, STD/SHORT, PHOENIX, IMPLANT CASE |
| 18257200117031 | LID, PHOENIX, IMPLANT CASE |
| 18257200117024 | TOP TRAY, PHOENIX, IMPLANT CASE |
| 18257200117017 | BOTTOM TRAY, PHOENIX, IMPLANT CASE |
| 18257200117000 | BASE, PHOENIX, IMPLANT CASE |
| 18257200116997 | LID, PHOENIX, INSTRUMENT CASE |
| 18257200116980 | TOP TRAY, PHOENIX, INSTRUMENT CASE |
| 18257200116973 | BOTTOM TRAY, PHOENIX, INSTRUMENT CASE |
| 18257200093663 | PHOENIX COMPRESSION/DISTRACTION TRAY KIT (20-0030) |
| 18257200087594 | ROD INSERTER, PHOENIX MIS SYSTEM |
| 18257200084388 | FAST DRIVE |
| 18257200082179 | PHOENIX (XRS) IMPLANTS CASE (20-0017) |
| 18257200080250 | Mono Axial Open Body Tall |
| 18257200080243 | Mono Axial Open Body Standard |
| 18257200080236 | Mono Axial Open Body Short |
| 18257200080212 | 90MM OFFET COMPRESSOR/DISTRACTOR TIP |
| 18257200080205 | 60MM OFFET COMPRESSOR/DISTRACTOR TIP |
| 18257200080199 | 30MM OFFET COMPRESSOR/DISTRACTOR TIP |
| 18257200080182 | STRAIGHT COMPRESSOR/DISTRACTOR TIP |
| 18257200080175 | DISTRACTOR |
| 18257200080168 | COMPRESSOR |
| 18257200080151 | SET SCREW DRIVER |
| 18257200080144 | DVR TOWER - TALL |
| 18257200080137 | DVR TOWER - STANDARD |
| 18257200080090 | MIS COUNTER-TORQUE TOWER |
| 18257200080083 | COMPRESSION-DISTRACTION FIXTURE |
| 18257200080076 | ROD INSERTER DRIVER |
| 18257200080052 | HANDLE ADAPTER |
| 18257200080045 | MONO-AXIAL SCREW DRIVER, PHOENIX |
| 18257200080038 | 10.5/11.5MM CANNULATED TAP SLEEVE ASSY |
| 18257200080021 | 8.5/9.5MM CANNULATED TAP SLEEVE ASSY |