MATRIXWAVE 04503821

GUDID H980045038210

MATRIXWAVE MMF TI PLATE 10 HOLES/TALL

SYNTHES (U.S.A.) LP

Craniofacial bone wire/bar

• Primary Device ID: H980045038210
• NIH Device Record Key: db442d9e-84b7-46bb-b592-aa1e07982be2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MATRIXWAVE
• Version Model Number: 04.503.821
• Catalog Number: 04503821
• Company DUNS: 832637081
• Company Name: SYNTHES (U.S.A.) LP
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10887587069449 [Primary]
HIBCC	H980045038210 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141165

FDA Product Code

• JEY: PLATE, BONE

Sterilization

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

[H980045038210]

Moist Heat or Steam Sterilization

[H980045038210]

Moist Heat or Steam Sterilization

[H980045038210]

Moist Heat or Steam Sterilization

[H980045038210]

Moist Heat or Steam Sterilization

[H980045038210]

Moist Heat or Steam Sterilization

[H980045038210]

Moist Heat or Steam Sterilization

[H980045038210]

Moist Heat or Steam Sterilization

[H980045038210]

Moist Heat or Steam Sterilization

[H980045038210]

Moist Heat or Steam Sterilization

[H980045038210]

Moist Heat or Steam Sterilization

[H980045038210]

Moist Heat or Steam Sterilization

[H980045038210]

Moist Heat or Steam Sterilization

[H980045038210]

Moist Heat or Steam Sterilization

[H980045038210]

Moist Heat or Steam Sterilization

[H980045038210]

Moist Heat or Steam Sterilization

[H980045038210]

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 [MATRIXWAVE]

• H98004503825050: MATRIXWAVE MMF TI 1.85MM SCREW SELF-DRILLING/8MM LENGTH
• H98004503824050: MATRIXWAVE MMF TI 1.85MM SCREW SELF-DRILLING/6MM LENGTH
• 07612334093486: MATRIXWAVE MMF APPLICATION INSTRUMENT
• H98004503825010: MATRIXWAVE MMF TI 1.85MM SCREW SELF-DRILLING/8MM LENGTH
• H98004503824010: MATRIXWAVE MMF TI 1.85MM SCREW SELF-DRILLING/6MM LENGTH
• H980045038210: MATRIXWAVE MMF TI PLATE 10 HOLES/TALL
• H980045038200: MATRIXWAVE MMF TI PLATE 10 HOLES/SHORT
• 07612334094780: MATRIXWAVE MMF SYSTEM INSERT TRAY ID TAG F/PLATES
• 07612334094773: MATRIXWAVE MMF INSERT TRAY ID TAG F/1.85MM LOCKING SCREWS
• 07612334094766: MATRIXWAVE MMF SYSTEM INSERT TRAY F/1.85MM LOCKING SCREWS
• 07612334094759: MATRIXWAVE MMF SYSTEM IMPLANT MODULE ID TAG
• 07612334093547: MATRIXWAVE MMF SYSTEM INSTRUMENT MODULE ID TAG
• 07612334093530: MATRIXWAVE MMF SYSTEM MODULE LID
• 07612334093523: MATRIXWAVE MMF SYSTEM IMPLANT MODULE BASE
• 07612334093516: MATRIXWAVE MMF SYSTEM INSTRUMENT MODULE BASE