446611

GUDID H9804466110

1.5MM TI Y-PLATE 1 X 3 HOLES-LOW PROFILE

SYNTHES (U.S.A.) LP

Craniofacial fixation plate, non-bioabsorbable

• Primary Device ID: H9804466110
• NIH Device Record Key: fd0f3d4b-a0e4-48ed-92c6-129b9b8e9152
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 446.611
• Catalog Number: 446611
• 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
• 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	10887587051932 [Primary]
HIBCC	H9804466110 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020087

FDA Product Code

• GXR: COVER, BURR HOLE

Sterilization

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

[H9804466110]

Moist Heat or Steam Sterilization

[H9804466110]

Moist Heat or Steam Sterilization

[H9804466110]

Moist Heat or Steam Sterilization

[H9804466110]

Moist Heat or Steam Sterilization

[H9804466110]

Moist Heat or Steam Sterilization

[H9804466110]

Moist Heat or Steam Sterilization

[H9804466110]

Moist Heat or Steam Sterilization

[H9804466110]

Moist Heat or Steam Sterilization

[H9804466110]

Moist Heat or Steam Sterilization

[H9804466110]

Moist Heat or Steam Sterilization

[H9804466110]

Moist Heat or Steam Sterilization

[H9804466110]

Moist Heat or Steam Sterilization

[H9804466110]

Moist Heat or Steam Sterilization

[H9804466110]

Moist Heat or Steam Sterilization

[H9804466110]

Moist Heat or Steam Sterilization

[H9804466110]

Moist Heat or Steam Sterilization

[H9804466110]

Moist Heat or Steam Sterilization

[H9804466110]

Moist Heat or Steam Sterilization

[H9804466110]

Moist Heat or Steam Sterilization

[H9804466110]

Moist Heat or Steam Sterilization

[H9804466110]

Moist Heat or Steam Sterilization

[H9804466110]

Moist Heat or Steam Sterilization

[H9804466110]

Moist Heat or Steam Sterilization

[H9804466110]

Moist Heat or Steam Sterilization

[H9804466110]

Moist Heat or Steam Sterilization

[H9804466110]

Moist Heat or Steam Sterilization

[H9804466110]

Moist Heat or Steam Sterilization

[H9804466110]

Moist Heat or Steam Sterilization

[H9804466110]

Moist Heat or Steam Sterilization

[H9804466110]

Moist Heat or Steam Sterilization

[H9804466110]

Moist Heat or Steam Sterilization

[H9804466110]

Moist Heat or Steam Sterilization

[H9804466110]

Moist Heat or Steam Sterilization

[H9804466110]

Moist Heat or Steam Sterilization

[H9804466110]

Moist Heat or Steam Sterilization

[H9804466110]

Moist Heat or Steam Sterilization

[H9804466110]

Moist Heat or Steam Sterilization

[H9804466110]

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

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