MatrixMANDIBLE SD317879

GUDID H980SD3178790

MATRIXMANDIBLE 1.8MM DRILL BIT J-LATCH/50MM

Synthes GmbH

Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable 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

On-Brand Devices [MatrixMANDIBLE]

• H980035031850: MATRIXMANDIBLE BENDNG TEMPLATE F/1.25MM 2X2H TENSION BAND PL
• H980035031750: MATRIXMANDIBLE BENDNG TEMPLATE F/2.0MM BROAD 3X3 ANGLE PLATE
• 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