TOMOFIX 324168
GUDID 07611819254701
2.0MM TOMOFIX(TM) GUIDE SLEEVE
SYNTHES (U.S.A.) LP
Surgical drill guide, reusable| Primary Device ID | 07611819254701 |
| NIH Device Record Key | e0c8fcd0-3c77-4927-a961-ab06a495c7e3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TOMOFIX |
| Version Model Number | 324.168 |
| Catalog Number | 324168 |
| 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 |
Customer Support Contacts
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07611819254701 [Direct Marking] |
| GS1 | 10886982191120 [Primary] |
| HIBCC | H6793241680 [Secondary] |
FDA Product Code
| FZX | Guide, surgical, instrument |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07611819254701]
Moist Heat or Steam Sterilization
[07611819254701]
Moist Heat or Steam Sterilization
[07611819254701]
Moist Heat or Steam Sterilization
[07611819254701]
Moist Heat or Steam Sterilization
[07611819254701]
Moist Heat or Steam Sterilization
[07611819254701]
Moist Heat or Steam Sterilization
[07611819254701]
Moist Heat or Steam Sterilization
[07611819254701]
Moist Heat or Steam Sterilization
[07611819254701]
Moist Heat or Steam Sterilization
[07611819254701]
Moist Heat or Steam Sterilization
[07611819254701]
Moist Heat or Steam Sterilization
[07611819254701]
Moist Heat or Steam Sterilization
[07611819254701]
Moist Heat or Steam Sterilization
[07611819254701]
Moist Heat or Steam Sterilization
[07611819254701]
Moist Heat or Steam Sterilization
[07611819254701]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-04-06 |
| Device Publish Date | 2016-12-31 |
On-Brand Devices [TOMOFIX]
| 07611819254701 | 2.0MM TOMOFIX(TM) GUIDE SLEEVE |
| H679440895S0 | TI TOMOFIX MEDIAL DISTAL FEMUR PL-4 HOLES/LT-STERILE |
| H6794408950 | TI TOMOFIX MEDIAL DISTAL FEMUR PLATE-4 HOLES/LEFT |
| H679440885S0 | TI TOMOFIX MEDIAL DISTAL FEMUR PL-4 HOLES/RT-STERILE |
| H6794408850 | TI TOMOFIX MEDIAL DISTAL FEMUR PLATE-4 HOLES/RIGHT |
Trademark Results [TOMOFIX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TOMOFIX 76467177 2981413 Live/Registered |
DEPUY SYNTHES, INC. 2002-11-05 |
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