SynMesh 495442
GUDID H9814954420
SYNMESH® 10MM DIA 7MM HEIGHT (TI)
SYNTHES (U.S.A.) LP
Vertebral body prosthesis| Primary Device ID | H9814954420 |
| NIH Device Record Key | bb026118-e089-4b74-a03d-d940b8eb1a96 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SynMesh |
| Version Model Number | 495.442 |
| Catalog Number | 495442 |
| Company DUNS | 832637081 |
| Company Name | SYNTHES (U.S.A.) LP |
| 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 | 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 |
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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 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10705034785868 [Primary] |
| HIBCC | H9814954420 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K983766
FDA Product Code
| EZX | Mesh, surgical, metal |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[H9814954420]
Moist Heat or Steam Sterilization
[H9814954420]
Moist Heat or Steam Sterilization
[H9814954420]
Moist Heat or Steam Sterilization
[H9814954420]
Moist Heat or Steam Sterilization
[H9814954420]
Moist Heat or Steam Sterilization
[H9814954420]
Moist Heat or Steam Sterilization
[H9814954420]
Moist Heat or Steam Sterilization
[H9814954420]
Moist Heat or Steam Sterilization
[H9814954420]
Moist Heat or Steam Sterilization
[H9814954420]
Moist Heat or Steam Sterilization
[H9814954420]
Moist Heat or Steam Sterilization
[H9814954420]
Moist Heat or Steam Sterilization
[H9814954420]
Moist Heat or Steam Sterilization
[H9814954420]
Moist Heat or Steam Sterilization
[H9814954420]
Moist Heat or Steam Sterilization
[H9814954420]
Moist Heat or Steam Sterilization
[H9814954420]
Moist Heat or Steam Sterilization
[H9814954420]
Moist Heat or Steam Sterilization
[H9814954420]
Moist Heat or Steam Sterilization
[H9814954420]
Moist Heat or Steam Sterilization
[H9814954420]
Moist Heat or Steam Sterilization
[H9814954420]
Moist Heat or Steam Sterilization
[H9814954420]
Moist Heat or Steam Sterilization
[H9814954420]
Moist Heat or Steam Sterilization
[H9814954420]
Moist Heat or Steam Sterilization
[H9814954420]
Moist Heat or Steam Sterilization
[H9814954420]
Moist Heat or Steam Sterilization
[H9814954420]
Moist Heat or Steam Sterilization
[H9814954420]
Moist Heat or Steam Sterilization
[H9814954420]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-10-02 |
| Device Publish Date | 2015-09-14 |
On-Brand Devices [SynMesh]
| 10705034817910 | SYNMESH® 10MM DIA 88MM HEIGHT (TI) |
| 07611819744462 | SYNMESH® IMPLANT HOLDER ANGLED |
| 07611819744455 | SYNMESH® IMPLANT HOLDER STRAIGHT |
| 07611819744448 | SYNMESH® IMPLANT HOLDER SMALL/ANGLED |
| 07611819744431 | SYNMESH® IMPLANT HOLDER SMALL/STRAIGHT |
| 07611819744424 | SYNMESH® IMPLANT HOLDER LARGE/WITH TIPS |
| 07611819744417 | SYNMESH® IMPLANT HOLDER SMALL/WITH TIPS |
| H9814956240 | SYNMESH® 15MM DIA 24MM HEIGHT (TI) |
| H9814956230 | SYNMESH® 15MM DIA 22MM HEIGHT (TI) |
| H9814956220 | SYNMESH® 15MM DIA 20MM HEIGHT (TI) |
| H9814956210 | SYNMESH® 15MM DIA 18MM HEIGHT (TI) |
| H9814956150 | SYNMESH® 12MM DIA 24MM HEIGHT (TI) |
| H9814956140 | SYNMESH® 12MM DIA 22MM HEIGHT (TI) |
| H9814956130 | SYNMESH® 12MM DIA 20MM HEIGHT (TI) |
| H9814956120 | SYNMESH® 12MM DIA 16MM HEIGHT (TI) |
| H9814956110 | SYNMESH® 12MM DIA 14MM HEIGHT (TI) |
| H9814956050 | SYNMESH® 10MM DIA 24MM HEIGHT (TI) |
| H9814956040 | SYNMESH® 10MM DIA 22MM HEIGHT (TI) |
| H9814956030 | SYNMESH® 10MM DIA 20MM HEIGHT (TI) |
| H9814956020 | SYNMESH® 10MM DIA 16MM HEIGHT (TI) |
| H9814956010 | SYNMESH® 10MM DIA 14MM HEIGHT (TI) |
| H9814954470 | SYNMESH® 10MM DIA 32MM HEIGHT (TI) |
| H9814953820 | SYNMESH® 26MM X 33MM 88MM HEIGHT (TI) |
| H9814953810 | SYNMESH® 26MM X 33MM 64MM HEIGHT (TI) |
| H9814953790 | SYNMESH® 22MM X 28MM 88MM HEIGHT (TI) |
| H9814953780 | SYNMESH® 22MM X 28MM 64MM HEIGHT (TI) |
| H9814953770 | SYNMESH® 22MM X 28MM 12MM HEIGHT (TI) |
| H9814953760 | SYNMESH® 22MM X 28MM 8MM HEIGHT (TI) |
| H9814953740 | SYNMESH® 17MM X 22MM 88MM HEIGHT (TI) |
| H9814953730 | SYNMESH® 17MM X 22MM 32MM HEIGHT (TI) |
| H9814953720 | SYNMESH® 17MM X 22MM 12MM HEIGHT (TI) |
| H9814953710 | SYNMESH® 17MM X 22MM 8MM HEIGHT (TI) |
| H9814953660 | SYNMESH® 15MM DIA 88MM HEIGHT (TI) |
| H9814953650 | SYNMESH® 15MM DIA 32MM HEIGHT (TI) |
| H9814953640 | SYNMESH® 15MM DIA 14MM HEIGHT (TI) |
| H9814953630 | SYNMESH® 15MM DIA 12MM HEIGHT (TI) |
| H9814953620 | SYNMESH® 15MM DIA 10MM HEIGHT (TI) |
| H9814953610 | SYNMESH® 15MM DIA 8MM HEIGHT (TI) |
| H9814953560 | SYNMESH® 12MM DIA 32MM HEIGHT (TI) |
| H9814953550 | SYNMESH® 12MM DIA 12MM HEIGHT (TI) |
| H9814953540 | SYNMESH® 12MM DIA 11MM HEIGHT (TI) |
| H9814953530 | SYNMESH® 12MM DIA 10MM HEIGHT (TI) |
| H9814953520 | SYNMESH® 12MM DIA 9MM HEIGHT (TI) |
| H9814953510 | SYNMESH® 12MM DIA 8MM HEIGHT (TI) |
| H9814954690 | SYNMESH® 17MM X 22MM 52MM HEIGHT (TI) |
| H9814954680 | SYNMESH® 17MM X 22MM 28MM HEIGHT (TI) |
| H9814954670 | SYNMESH® 17MM X 22MM 26MM HEIGHT (TI) |
| H9814954660 | SYNMESH® 17MM X 22MM 24MM HEIGHT (TI) |
| H9814954650 | SYNMESH® 17MM X 22MM 22MM HEIGHT (TI) |
| H9814954640 | SYNMESH® 17MM X 22MM 20MM HEIGHT (TI) |
Trademark Results [SynMesh]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SYNMESH 75648022 2502525 Live/Registered |
DEPUY SYNTHES, INC. 1999-02-23 |
 SYNMESH 72185101 0782915 Dead/Expired |
ASTEN-HILL MFG. COMPANY 1964-01-22 |
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