SD03503422

GUDID 10887587076720

MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH W/ 22MM STOP/50MM

SYNTHES (U.S.A.) LP

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

• Primary Device ID: 10887587076720
• NIH Device Record Key: ab05c37d-2d7f-4a44-ab8f-3db3c12cb366
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: SD03.503.422
• Catalog Number: SD03503422
• 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: 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
• 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	10887587076720 [Primary]

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

[10887587076720]

Moist Heat or Steam Sterilization

[10887587076720]

Moist Heat or Steam Sterilization

[10887587076720]

Moist Heat or Steam Sterilization

[10887587076720]

Moist Heat or Steam Sterilization

[10887587076720]

Moist Heat or Steam Sterilization

[10887587076720]

Moist Heat or Steam Sterilization

[10887587076720]

Moist Heat or Steam Sterilization

[10887587076720]

Moist Heat or Steam Sterilization

[10887587076720]

Moist Heat or Steam Sterilization

[10887587076720]

Moist Heat or Steam Sterilization

[10887587076720]

Moist Heat or Steam Sterilization

[10887587076720]

Moist Heat or Steam Sterilization

[10887587076720]

Moist Heat or Steam Sterilization

[10887587076720]

Moist Heat or Steam Sterilization

[10887587076720]

Moist Heat or Steam Sterilization

[10887587076720]

Moist Heat or Steam Sterilization

[10887587076720]

Moist Heat or Steam Sterilization

[10887587076720]

Moist Heat or Steam Sterilization

[10887587076720]

Moist Heat or Steam Sterilization

[10887587076720]

Moist Heat or Steam Sterilization

[10887587076720]

Moist Heat or Steam Sterilization

[10887587076720]

Moist Heat or Steam Sterilization

[10887587076720]

Moist Heat or Steam Sterilization

[10887587076720]

Moist Heat or Steam Sterilization

[10887587076720]

Moist Heat or Steam Sterilization

[10887587076720]

Moist Heat or Steam Sterilization

[10887587076720]

Moist Heat or Steam Sterilization

[10887587076720]

Moist Heat or Steam Sterilization

[10887587076720]

Moist Heat or Steam Sterilization

[10887587076720]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-22
• Device Publish Date: 2021-07-14

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• H679022221200 - NA: 2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/20MM
• H679022221220 - NA: 2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/22MM
• H679022221240 - NA: 2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/24MM
• H679022221260 - NA: 2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/26MM