PlusDrive 401295

GUDID H9804012950

2.0MM TI LCKNG SCREW SLF-TPNG W/PLUSDRIVE(TM) RECESS 10MM

SYNTHES (U.S.A.) LP

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable

Primary Device ID	H9804012950
NIH Device Record Key	63363993-f3c6-421f-b41c-370d380bd8c3
Commercial Distribution Status	In Commercial Distribution
Brand Name	PlusDrive
Version Model Number	401.295
Catalog Number	401295
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
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	20887587046591 [Primary]
GS1	80887587046593 [Unit of Use]
HIBCC	H9804012950 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K162594
Premarket Notification: K974555

FDA Product Code

JEY	PLATE, BONE

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[H9804012950]

Moist Heat or Steam Sterilization

[H9804012950]

Moist Heat or Steam Sterilization

[H9804012950]

Moist Heat or Steam Sterilization

[H9804012950]

Moist Heat or Steam Sterilization

[H9804012950]

Moist Heat or Steam Sterilization

[H9804012950]

Moist Heat or Steam Sterilization

[H9804012950]

Moist Heat or Steam Sterilization

[H9804012950]

Moist Heat or Steam Sterilization

[H9804012950]

Moist Heat or Steam Sterilization

[H9804012950]

Moist Heat or Steam Sterilization

[H9804012950]

Moist Heat or Steam Sterilization

[H9804012950]

Moist Heat or Steam Sterilization

[H9804012950]

Moist Heat or Steam Sterilization

[H9804012950]

Moist Heat or Steam Sterilization

[H9804012950]

Moist Heat or Steam Sterilization

[H9804012950]

Moist Heat or Steam Sterilization

[H9804012950]

Moist Heat or Steam Sterilization

[H9804012950]

Moist Heat or Steam Sterilization

[H9804012950]

Moist Heat or Steam Sterilization

[H9804012950]

Moist Heat or Steam Sterilization

[H9804012950]

Moist Heat or Steam Sterilization

[H9804012950]

Moist Heat or Steam Sterilization

[H9804012950]

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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