Primary Device ID | 07611819973091 |
NIH Device Record Key | 49b8cf0f-315c-45ec-bf52-af0dc89d396c |
Commercial Distribution Discontinuation | 2020-09-17 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SynFix-LR |
Version Model Number | 03.802.020 |
Catalog Number | 03802020 |
Company DUNS | 832637081 |
Company Name | SYNTHES (U.S.A.) LP |
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 | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07611819973091 [Direct Marking] |
GS1 | 10705034722153 [Primary] |
HIBCC | H981038020200 [Secondary] |
FZX | Guide, surgical, instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[07611819973091]
Moist Heat or Steam Sterilization
[07611819973091]
Moist Heat or Steam Sterilization
[07611819973091]
Moist Heat or Steam Sterilization
[07611819973091]
Moist Heat or Steam Sterilization
[07611819973091]
Moist Heat or Steam Sterilization
[07611819973091]
Moist Heat or Steam Sterilization
[07611819973091]
Moist Heat or Steam Sterilization
[07611819973091]
Moist Heat or Steam Sterilization
[07611819973091]
Moist Heat or Steam Sterilization
[07611819973091]
Moist Heat or Steam Sterilization
[07611819973091]
Moist Heat or Steam Sterilization
[07611819973091]
Moist Heat or Steam Sterilization
[07611819973091]
Moist Heat or Steam Sterilization
[07611819973091]
Moist Heat or Steam Sterilization
[07611819973091]
Moist Heat or Steam Sterilization
[07611819973091]
Moist Heat or Steam Sterilization
[07611819973091]
Moist Heat or Steam Sterilization
[07611819973091]
Moist Heat or Steam Sterilization
[07611819973091]
Moist Heat or Steam Sterilization
[07611819973091]
Moist Heat or Steam Sterilization
[07611819973091]
Moist Heat or Steam Sterilization
[07611819973091]
Moist Heat or Steam Sterilization
[07611819973091]
Moist Heat or Steam Sterilization
[07611819973091]
Moist Heat or Steam Sterilization
[07611819973091]
Moist Heat or Steam Sterilization
[07611819973091]
Moist Heat or Steam Sterilization
[07611819973091]
Moist Heat or Steam Sterilization
[07611819973091]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2020-08-31 |
Device Publish Date | 2016-12-31 |
H981608021030 | MODULE FOR 4.0MM TI SYNFIX(TM)-LR LOCKING SCREWS |
07611819297227 | SCREW HOLDING INSTRUMENT FOR SYNFIX(TM)-LR |
07611819297234 | IMPLANT HOLDER FOR SYNFIX(TM)-LR |
H98108802004S0 | SYNFIX(TM)-LR 26MM DEPTH/32MM WIDTH/13.5MM HEIGHT 12DEG-STER |
H98108802003S0 | SYNFIX(TM)-LR 26MM DEPTH/32MM WIDTH/19MM HEIGHT 8DEG-STER |
H98108802002S0 | SYNFIX(TM)-LR 26MM DEPTH/32MM WIDTH/17MM HEIGHT 8DEG-STER |
H98108802001S0 | SYNFIX(TM)-LR 26MM DEPTH/32MM WIDTH/15MM HEIGHT 8DEG-STER |
H98108802000S0 | SYNFIX(TM)-LR 26MM DEPTH/32MM WIDTH/13.5MM HEIGHT 8DEG-STER |
H981048022130 | 4.0MM TI LOCKING SCREW-FINE TIP 30MM FOR SYNFIX-LR |
07611819310988 | 19MM AIMING DEVICE-MODIFIED FOR SYNFIX-LR |
07611819310971 | 17MM AIMING DEVICE-MODIFIED FOR SYNFIX-LR |
07611819310964 | 15MM AIMING DEVICE-MODIFIED FOR SYNFIX-LR |
07611819310957 | 13.5MM AIMING DEVICE-MODIFIED FOR SYNFIX-LR |
07611819310940 | 12MM AIMING DEVICE-MODIFIED FOR SYNFIX-LR |
07611819939028 | SYNFIX(TM)-LR QUICK INSERTER/DISTRACTOR (SQUID) |
07611819297425 | PACKING BLOCK FOR 30MM DEPTH/ 38MM WIDTH SYNFIX(TM)-LR |
07611819791268 | PACKING BLOCK FOR 26MM DEPTH/ 32MM WIDTH SYNFIX(TM)-LR |
07611819791251 | AIMING DEVICE 15MM FOR SYNFIX(TM)-LR |
07611819297272 | AIMING DEVICE 19MM FOR SYNFIX(TM)-LR |
07611819297265 | AIMING DEVICE 17MM FOR SYNFIX(TM)-LR |
07611819297258 | AIMING DEVICE 13.5MM FOR SYNFIX(TM)-LR |
07611819297197 | AIMING DEVICE HOLDER FOR SYNFIX(TM)-LR |
07611819973091 | AIMING DEVICE FOR 12MM SYNFIX-LR |
07611819973084 | SYNFIX-LR TRIAL IMPLANT 12DEG DEPTH 30MM/W 38MM/H 12MM |
07611819973077 | SYNFIX-LR TRIAL IMPLANT 8DEG DEPTH 30MM/W 38MM/H 12MM |
07611819973060 | SYNFIX-LR TRIAL IMPLANT 12DEG DEPTH 26MM/W 32MM/H 12MM |
07611819973053 | SYNFIX-LR TRIAL IMPLANT 8DEG DEPTH 26MM/W 32MM/H 12MM |
H981608091500 | SYNFIX® LR IMPLANT HOLDER GRAPHIC CASE |
H981608022400 | MODULE FOR SYNFIX-LR AIMING DEVICES |
H981608021300 | GRAPHIC CASE FOR SYNFIX-LR TRIAL SPACERS AND SCREWS |
H981608021100 | GRAPHIC CASE FOR SYNFIX-LR STANDARD INSTRUMENTS |
H98108802019S0 | SYNFIX-LR 30MM DEPTH/38MM WIDTH/12MM HEIGHT 12DEG-STER |
H98108802018S0 | SYNFIX-LR 30MM DEPTH/38MM WIDTH/12MM HEIGHT 8DEG-STER |
H98108802017S0 | SYNFIX-LR 26MM DEPTH/32MM WIDTH/12MM HEIGHT 12DEG-STER |
H98108802016S0 | SYNFIX-LR 26MM DEPTH/32MM WIDTH/12MM HEIGHT 8DEG-STER |
H98108802015S0 | SYNFIX(TM)-LR 30MM DEPTH/38MM WIDTH/19MM HEIGHT 12DEG-STER |
H98108802014S0 | SYNFIX(TM)-LR 30MM DEPTH/38MM WIDTH/17MM HEIGHT 12DEG-STER |
H98108802013S0 | SYNFIX(TM)-LR 30MM DEPTH/38MM WIDTH/15MM HEIGHT 12DEG-STER |
H98108802012S0 | SYNFIX(TM)-LR 30MM DEPTH/38MM WIDTH/13.5MM HEIGHT 12DEG-STER |
H98108802011S0 | SYNFIX(TM)-LR 30MM DEPTH/38MM WIDTH/19MM HEIGHT 8DEG-STER |
H98108802010S0 | SYNFIX(TM)-LR 30MM DEPTH/38MM WIDTH/17MM HEIGHT 8DEG-STER |
H98108802009S0 | SYNFIX(TM)-LR 30MM DEPTH/38MM WIDTH/15MM HEIGHT 8DEG-STER |
H98108802008S0 | SYNFIX(TM)-LR 30MM DEPTH/38MM WIDTH/13.5MM HEIGHT 8DEG-STER |
H98108802007S0 | SYNFIX(TM)-LR 26MM DEPTH/32MM WIDTH/19MM HEIGHT 12DEG-STER |
H98108802006S0 | SYNFIX(TM)-LR 26MM DEPTH/32MM WIDTH/17MM HEIGHT 12DEG-STER |
H98108802005S0 | SYNFIX(TM)-LR 26MM DEPTH/32MM WIDTH/15MM HEIGHT 12DEG-STER |
H981048022120 | 4.0MM TI LOCKING SCREW-FINE TIP 25MM FOR SYNFIX-LR |
H981048022110 | 4.0MM TI LOCKING SCREW-FINE TIP 20MM FOR SYNFIX-LR |
H981048022100 | 4.0MM TI LOCKING SCREW-FINE TIP 15MM FOR SYNFIX-LR |
H981048022030 | 4.0MM TI LOCKING SCREW 30MM FOR SYNFIX(TM)-LR |