SD310040

GUDID H980SD3100400

1.5MM DRILL BIT WITH 6MM STOP F/2.0MM THREADED DRILL GUIDE

Synthes GmbH

Fluted surgical drill bit, reusable

• Primary Device ID: H980SD3100400
• NIH Device Record Key: 10922db3-9756-4f5f-bbfb-ffeb0089fb80
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: SD310.040
• Catalog Number: SD310040
• 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	10887587001838 [Primary]
HIBCC	H980SD3100400 [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

[H980SD3100400]

Moist Heat or Steam Sterilization

[H980SD3100400]

Moist Heat or Steam Sterilization

[H980SD3100400]

Moist Heat or Steam Sterilization

[H980SD3100400]

Moist Heat or Steam Sterilization

[H980SD3100400]

Moist Heat or Steam Sterilization

[H980SD3100400]

Moist Heat or Steam Sterilization

[H980SD3100400]

Moist Heat or Steam Sterilization

[H980SD3100400]

Moist Heat or Steam Sterilization

[H980SD3100400]

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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• 07612334292100 - NA: 2024-08-02 TRAY FOR REDUCTION AND SCREW INSERTION INSTRUMENTS
• 07612334292117 - NA: 2024-08-02 TRAY FOR LCP PLATES
• 07612334292124 - NA: 2024-08-02 SCREW CADDY
• 07612334292131 - NA: 2024-08-02 TRAY F/WIRE IMPL & INSTRUMENTS
• 10886982347466 - NA: 2024-08-02 RIGID INSERTION SLEEVE