PlusDrive 401050
GUDID H9804010500
2.0MM TI CRTX SCR COARSE PITCH SLF-TPNG W/PLUSDRIVE(TM) 20MM
SYNTHES (U.S.A.) LP
Orthopaedic bone screw, non-bioabsorbable, non-sterile| Primary Device ID | H9804010500 |
| NIH Device Record Key | 882528b5-fb8a-4a96-8a47-237cd8051dbb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PlusDrive |
| Version Model Number | 401.050 |
| Catalog Number | 401050 |
| Company DUNS | 832637081 |
| Company Name | SYNTHES (U.S.A.) LP |
| Device Count | 5 |
| 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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 20887587045921 [Primary] |
| GS1 | 80887587045923 [Unit of Use] |
| HIBCC | H9804010500 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K102656
FDA Product Code
| JEY | PLATE, BONE |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[H9804010500]
Moist Heat or Steam Sterilization
[H9804010500]
Moist Heat or Steam Sterilization
[H9804010500]
Moist Heat or Steam Sterilization
[H9804010500]
Moist Heat or Steam Sterilization
[H9804010500]
Moist Heat or Steam Sterilization
[H9804010500]
Moist Heat or Steam Sterilization
[H9804010500]
Moist Heat or Steam Sterilization
[H9804010500]
Moist Heat or Steam Sterilization
[H9804010500]
Moist Heat or Steam Sterilization
[H9804010500]
Moist Heat or Steam Sterilization
[H9804010500]
Moist Heat or Steam Sterilization
[H9804010500]
Moist Heat or Steam Sterilization
[H9804010500]
Moist Heat or Steam Sterilization
[H9804010500]
Moist Heat or Steam Sterilization
[H9804010500]
Moist Heat or Steam Sterilization
[H9804010500]
Moist Heat or Steam Sterilization
[H9804010500]
Moist Heat or Steam Sterilization
[H9804010500]
Moist Heat or Steam Sterilization
[H9804010500]
Moist Heat or Steam Sterilization
[H9804010500]
Moist Heat or Steam Sterilization
[H9804010500]
Moist Heat or Steam Sterilization
[H9804010500]
Moist Heat or Steam Sterilization
[H9804010500]
Moist Heat or Steam Sterilization
[H9804010500]
Moist Heat or Steam Sterilization
[H9804010500]
Moist Heat or Steam Sterilization
[H9804010500]
Moist Heat or Steam Sterilization
[H9804010500]
Moist Heat or Steam Sterilization
[H9804010500]
Moist Heat or Steam Sterilization
[H9804010500]
Moist Heat or Steam Sterilization
[H9804010500]
Moist Heat or Steam Sterilization
[H9804010500]
Moist Heat or Steam Sterilization
[H9804010500]
Moist Heat or Steam Sterilization
[H9804010500]
Moist Heat or Steam Sterilization
[H9804010500]
Moist Heat or Steam Sterilization
[H9804010500]
Moist Heat or Steam Sterilization
[H9804010500]
Moist Heat or Steam Sterilization
[H9804010500]
Moist Heat or Steam Sterilization
[H9804010500]
Moist Heat or Steam Sterilization
[H9804010500]
Moist Heat or Steam Sterilization
[H9804010500]
Moist Heat or Steam Sterilization
[H9804010500]
Moist Heat or Steam Sterilization
[H9804010500]
Moist Heat or Steam Sterilization
[H9804010500]
Moist Heat or Steam Sterilization
[H9804010500]
Moist Heat or Steam Sterilization
[H9804010500]
Moist Heat or Steam Sterilization
[H9804010500]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-09-14 |
On-Brand Devices [PlusDrive]
| H9804019570 | 2.0MM TI LCKNG SCREW SLF-DRLG W/PLUSDRIVE(TM) RECESS 8MM |
| H9804019560 | 2.0MM TI LCKNG SCREW SLF-DRLG W/PLUSDRIVE(TM) RECESS 6MM |
| H9804019550 | 2.0MM TI LCKNG SCREW SLF-DRLG W/PLUSDRIVE(TM) RECESS 5MM |
| H9804017990 | 2.4MM TI EMERGENCY SCREW WITH PLUSDRIVE(TM) RECESS 18MM |
| H9804017980 | 2.4MM TI EMERGENCY SCREW WITH PLUSDRIVE(TM) RECESS 16MM |
| H9804017970 | 2.4MM TI EMERGENCY SCREW WITH PLUSDRIVE(TM) RECESS 14MM |
| H9804017960 | 2.4MM TI EMERGENCY SCREW WITH PLUSDRIVE(TM) RECESS 12MM |
| H9804017950 | 2.4MM TI EMERGENCY SCREW WITH PLUSDRIVE(TM) RECESS 10MM |
| H9804017940 | 2.4MM TI EMERGENCY SCREW WITH PLUSDRIVE(TM) RECESS 8MM |
| H9804017920 | 2.4MM TI EMERGENCY SCREW WITH PLUSDRIVE(TM) RECESS 6MM |
| H9804017910 | 2.4MM TI EMERGENCY SCREW WITH PLUSDRIVE(TM) RECESS 5MM |
| H9804012990 | 2.0MM TI LCKNG SCREW SLF-TPNG W/PLUSDRIVE(TM) RECESS 18MM |
| H9804012980 | 2.0MM TI LCKNG SCREW SLF-TPNG W/PLUSDRIVE(TM) RECESS 16MM |
| H9804012970 | 2.0MM TI LCKNG SCREW SLF-TPNG W/PLUSDRIVE(TM) RECESS 14MM |
| H9804012960 | 2.0MM TI LCKNG SCREW SLF-TPNG W/PLUSDRIVE(TM) RECESS 12MM |
| H9804012950 | 2.0MM TI LCKNG SCREW SLF-TPNG W/PLUSDRIVE(TM) RECESS 10MM |
| H9804012940 | 2.0MM TI LCKNG SCREW SLF-TPNG W/PLUSDRIVE(TM) RECESS 8MM |
| H9804012920 | 2.0MM TI LCKNG SCREW SLF-TPNG W/PLUSDRIVE(TM) RECESS 6MM |
| H9804012910 | 2.0MM TI LCKNG SCREW SLF-TPNG W/PLUSDRIVE(TM) RECESS 5MM |
| H9804010650 | 2.0MM TI CRTX SCREW SLF-DRLG W/PLUSDRIVE(TM) RECESS 8MM |
| H9804010640 | 2.0MM TI CRTX SCREW SLF-DRLG W/PLUSDRIVE(TM) RECESS 7MM |
| H9804010630 | 2.0MM TI CRTX SCREW SLF-DRLG W/PLUSDRIVE(TM) RECESS 6MM |
| H9804010620 | 2.0MM TI CRTX SCREW SLF-DRLG W/PLUSDRIVE(TM) RECESS 5MM |
| H9804010610 | 2.0MM TI CRTX SCREW SLF-DRLG W/PLUSDRIVE(TM) RECESS 4MM |
| H9804010520 | 2.0MM TI CRTX SCR COARSE PITCH SLF-TPNG W/PLUSDRIVE(TM) 24MM |
| H9804010510 | 2.0MM TI CRTX SCR COARSE PITCH SLF-TPNG W/PLUSDRIVE(TM) 22MM |
| H9804010500 | 2.0MM TI CRTX SCR COARSE PITCH SLF-TPNG W/PLUSDRIVE(TM) 20MM |
| H9804010490 | 2.0MM TI CRTX SCR COARSE PITCH SLF-TPNG W/PLUSDRIVE(TM) 18MM |
| H9804010480 | 2.0MM TI CRTX SCR COARSE PITCH SLF-TPNG W/PLUSDRIVE(TM) 16MM |
| H9804010470 | 2.0MM TI CRTX SCR COARSE PITCH SLF-TPNG W/PLUSDRIVE(TM) 14MM |
| H9804010460 | 2.0MM TI CRTX SCR COARSE PITCH SLF-TPNG W/PLUSDRIVE(TM) 12MM |
| H9804010450 | 2.0MM TI CRTX SCR COARSE PITCH SLF-TPNG W/PLUSDRIVE(TM) 10MM |
| H9804010440 | 2.0MM TI CRTX SCREW SLF-TPNG W/PLUSDRIVE(TM) RECESS 8MM |
| H9804010430 | 2.0MM TI CRTX SCREW SLF-TPNG W/PLUSDRIVE(TM) RECESS 6MM |
| H9804010420 | 2.0MM TI CRTX SCREW SLF-TPNG W/PLUSDRIVE(TM) RECESS 5MM |
| H9804010410 | 2.0MM TI CRTX SCREW SLF-TPNG W/PLUSDRIVE(TM) RECESS 4MM |
| 20887587043859 | 1.7MM TI EMERGENCY SCREW WITH PLUSDRIVE(TM) RECESS 18MM |
| 20887587043828 | 1.7MM TI EMERGENCY SCREW WITH PLUSDRIVE(TM) RECESS 16MM |
| 20887587043798 | 1.7MM TI EMERGENCY SCREW WITH PLUSDRIVE(TM) RECESS 14MM |
| 20887587043767 | 1.7MM TI EMERGENCY SCREW WITH PLUSDRIVE(TM) RECESS 12MM |
| 20887587043736 | 1.7MM TI EMERGENCY SCREW WITH PLUSDRIVE(TM) RECESS 10MM |
| 20887587043682 | 1.7MM TI EMERGENCY SCREW WITH PLUSDRIVE(TM) RECESS 8MM |
| 20887587043637 | 1.7MM TI EMERGENCY SCREW WITH PLUSDRIVE(TM) RECESS 6MM |
| 20887587043606 | 1.7MM TI EMERGENCY SCREW WITH PLUSDRIVE(TM) RECESS 5MM |
| 20887587043576 | 1.7MM TI EMERGENCY SCREW WITH PLUSDRIVE(TM) RECESS 4MM |
| 20887587043545 | 1.7MM TI EMERGENCY SCREW WITH PLUSDRIVE(TM) RECESS 3MM |
| 20887587043521 | 1.2MM TI EMERGENCY SCREW WITH PLUSDRIVE(TM) RECESS 14MM |
| 20887587043507 | 1.2MM TI EMERGENCY SCREW WITH PLUSDRIVE(TM) RECESS 12MM |
| 20887587043484 | 1.2MM TI EMERGENCY SCREW WITH PLUSDRIVE(TM) RECESS 11MM |
| 20887587043460 | 1.2MM TI EMERGENCY SCREW WITH PLUSDRIVE(TM) RECESS 10MM |
Trademark Results [PlusDrive]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PLUSDRIVE 97139604 not registered Live/Pending |
PlusAI, Inc. 2021-11-23 |
 PLUSDRIVE 97138145 not registered Live/Pending |
PlusAI, Inc. 2021-11-22 |
 PLUSDRIVE 90109211 not registered Live/Pending |
PlusAI Inc. 2020-08-12 |
 PLUSDRIVE 79080334 3835404 Dead/Cancelled |
ESTsoft Corp. 2009-12-24 |
 PLUSDRIVE 76551726 3029814 Live/Registered |
DEPUY SYNTHES, INC. 2003-10-10 |
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