MatrixMANDIBLE SD317879

GUDID H980SD3178790

MATRIXMANDIBLE 1.8MM DRILL BIT J-LATCH/50MM

Synthes GmbH

Fluted surgical drill bit, reusable

• Primary Device ID: H980SD3178790
• NIH Device Record Key: 9bf3bf6b-c750-44c2-9177-739bacfa0fd2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MatrixMANDIBLE
• Version Model Number: SD317.879
• Catalog Number: SD317879
• Company DUNS: 486711679
• Company Name: Synthes GmbH
• 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: 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
• 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	10887587002538 [Primary]
HIBCC	H980SD3178790 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043310

FDA Product Code

• DZI: DRILL, BONE, POWERED

Sterilization

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

[H980SD3178790]

Moist Heat or Steam Sterilization

[H980SD3178790]

Moist Heat or Steam Sterilization

[H980SD3178790]

Moist Heat or Steam Sterilization

[H980SD3178790]

Moist Heat or Steam Sterilization

[H980SD3178790]

Moist Heat or Steam Sterilization

[H980SD3178790]

Moist Heat or Steam Sterilization

[H980SD3178790]

Moist Heat or Steam Sterilization

[H980SD3178790]

Moist Heat or Steam Sterilization

[H980SD3178790]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-25
• Device Publish Date: 2022-07-15

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• H980035031730: MATRIXMANDIBLE BENDNG TEMPLATE F/2.0MM BROAD CRESCENT PLATES
• H980035031710: MATRIXMANDIBLE BENDNG TEMPLATE F/1.5MM 6H CRESCENT PLATES
• H980035031700: MATRIXMANDIBLE BENDNG TEMPLATE F/1.5MM THICK 3X3 ANGLE PLATE
• H980035031690: MATRIXMANDIBLE BENDNG TEMPLATE F/1.5MM THK 3X3 STRAIGHT PLAT
• H980035031660: MATRIXMANDIBLE BENDNG TEMPLATE F/1.25MM THICK ANGLE PLATES
• H980035031650: MATRIXMANDIBLE BENDNG TEMPLATE F/1.25MM 3X3 CRESCENT PLATES
• H980035031640: MATRIXMANDIBLE BENDNG TEMPLATE F/1.25MM 2X2 CRESCENT PLATES
• H980035031610: MATRIXMANDIBLE BENDNG TEMPLATE F/1.0MM BROAD TENSION BAND PL
• H980035030700: MATRIXMANDIBLE/THORAX SCRWDRVR BLADE SELF RETAINING-SHORT
• H980035030690: MATRIXMANDIBLE HOLDING SLEEVE LONG FOR USE WITH 03.503.068
• 10887587034607: GRAPHIC CASE MEDIUM FOR MATRIXMANDIBLE SYSTEM
• H980SD3178790: MATRIXMANDIBLE 1.8MM DRILL BIT J-LATCH/50MM