PlusDrive 400402

GUDID H9804004020

1.0MM TI CRTX SCREW SLF-TPNG W/PLUSDRIVE(TM) RECESS 2MM

SYNTHES (U.S.A.) LP

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: H9804004020
• NIH Device Record Key: b233f20c-6574-4b14-aaac-1864d07e1c5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PlusDrive
• Version Model Number: 400.402
• Catalog Number: 400402
• 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
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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
• 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
• 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	20887587042593 [Primary]
GS1	80887587042595 [Unit of Use]
HIBCC	H9804004020 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K912932

FDA Product Code

• HRS: PLATE, FIXATION, BONE

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

Moist Heat or Steam Sterilization

[H9804004020]

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