Primary Device ID | 07611819256118 |
NIH Device Record Key | 0d2a7600-0b97-4d26-aec1-be5576029138 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | TOMOFIX |
Version Model Number | 312.926 |
Catalog Number | 312926 |
Company DUNS | 486711679 |
Company Name | Synthes GmbH |
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 |
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Phone | +1(800)255-2500 |
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Phone | +1(800)255-2500 |
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Phone | +1(800)255-2500 |
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Phone | +1(800)255-2500 |
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Phone | +1(800)255-2500 |
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Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
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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 |
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Phone | +1(800)255-2500 |
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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 | 07611819256118 [Direct Marking] |
GS1 | 10886982188052 [Primary] |
HIBCC | H6793129260 [Secondary] |
FZX | Guide, surgical, instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[07611819256118]
Moist Heat or Steam Sterilization
[07611819256118]
Moist Heat or Steam Sterilization
[07611819256118]
Moist Heat or Steam Sterilization
[07611819256118]
Moist Heat or Steam Sterilization
[07611819256118]
Moist Heat or Steam Sterilization
[07611819256118]
Moist Heat or Steam Sterilization
[07611819256118]
Moist Heat or Steam Sterilization
[07611819256118]
Moist Heat or Steam Sterilization
[07611819256118]
Moist Heat or Steam Sterilization
[07611819256118]
Moist Heat or Steam Sterilization
[07611819256118]
Moist Heat or Steam Sterilization
[07611819256118]
Moist Heat or Steam Sterilization
[07611819256118]
Moist Heat or Steam Sterilization
[07611819256118]
Moist Heat or Steam Sterilization
[07611819256118]
Moist Heat or Steam Sterilization
[07611819256118]
Moist Heat or Steam Sterilization
[07611819256118]
Moist Heat or Steam Sterilization
[07611819256118]
Moist Heat or Steam Sterilization
[07611819256118]
Moist Heat or Steam Sterilization
[07611819256118]
Moist Heat or Steam Sterilization
[07611819256118]
Moist Heat or Steam Sterilization
[07611819256118]
Moist Heat or Steam Sterilization
[07611819256118]
Moist Heat or Steam Sterilization
[07611819256118]
Moist Heat or Steam Sterilization
[07611819256118]
Moist Heat or Steam Sterilization
[07611819256118]
Moist Heat or Steam Sterilization
[07611819256118]
Moist Heat or Steam Sterilization
[07611819256118]
Moist Heat or Steam Sterilization
[07611819256118]
Moist Heat or Steam Sterilization
[07611819256118]
Moist Heat or Steam Sterilization
[07611819256118]
Moist Heat or Steam Sterilization
[07611819256118]
Moist Heat or Steam Sterilization
[07611819256118]
Moist Heat or Steam Sterilization
[07611819256118]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2022-04-29 |
Device Publish Date | 2016-12-31 |
H679031200690 | TOMOFIX GUIDING BLOCK FOR MEDIAL DISTAL FEMUR PLATE-LT |
H679031200680 | TOMOFIX GUIDING BLOCK FOR MEDIAL DISTAL FEMUR PLATE-RT |
07611819256156 | TOMOFIX(TM) GUIDING BLOCK FOR LATERAL DISTAL FEMUR-LEFT |
07611819256149 | TOMOFIX(TM) GUIDING BLOCK FOR LATERAL DISTAL FEMUR-RIGHT |
07611819256132 | TOMOFIX(TM) GUIDING BLOCK FOR LATERAL HIGH TIBIA-LEFT |
07611819256125 | TOMOFIX(TM) GUIDING BLOCK FOR LATERAL HIGH TIBIA-RIGHT |
07611819256118 | TOMOFIX(TM) GUIDING BLOCK FOR MEDIAL HIGH TIBIA |
07611819941885 | TOMOFIX GUIDING BLOCK F/MEDIAL HIGH TIBIA PLATE-SMALL |
H67904120551S0 | TI TOMOFIX MEDIAL DISTAL FEMUR PL/4 HOLES/LEFT-STERILE |
H679041205510 | TI TOMOFIX MEDIAL DISTAL FEMUR PLATE - 4 HOLES/LEFT |
H67904120550S0 | TI TOMOFIX MEDIAL DISTAL FEMUR PL/4 HOLES/RIGHT-STERILE |
H679041205500 | TI TOMOFIX MEDIAL DISTAL FEMUR PLATE - 4 HOLES/RIGHT |
H6796712980 | SYNCASE FOR TOMOFIX(TM) SCREW SET |
H6796712940 | SYNCASE FOR TOMOFIX(TM) INSTRUMENT SET |
H679601200500 | TOMOFIX INSTRUMENT AND TI IMPLANT SET GRAPHIC CASE |
H6794408740 | TI TOMOFIX(TM) LATERAL DISTAL FEMUR PLATE-4 HOLES/LEFT |
H6794408640 | TI TOMOFIX(TM) LATERAL DISTAL FEMUR PLATE-4 HOLES/RIGHT |
H6794408530 | TI TOMOFIX(TM) LATERAL HIGH TIBIA PLATE-3 HOLES/LEFT |
H6794408430 | TI TOMOFIX(TM) LATERAL HIGH TIBIA PLATE-3 HOLES/RIGHT |
H6794408340 | TI TOMOFIX(TM) MEDIAL HIGH TIBIA PLATE-4 HOLES |
H6794408310 | TI TOMOFIX MEDIAL HIGH TIBIA PLATE-4 HOLES/SMALL |
07611819275737 | TOMOFIX OSTEOTOMY CHISEL 25MM WIDTH |
07611819275720 | TOMOFIX OSTEOTOMY CHISEL 20MM WIDTH |
07611819275713 | TOMOFIX OSTEOTOMY CHISEL 15MM WIDTH |
07611819275706 | TOMOFIX OSTEOTOMY CHISEL 10MM WIDTH |
07611819284951 | TOMOFIX(TM) OSTEOTOMY GAP MEASURING DEVICE |
07611819278721 | TOMOFIX(TM) BONE SPREADER |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
TOMOFIX 76467177 2981413 Live/Registered |
DEPUY SYNTHES, INC. 2002-11-05 |