210451

GUDID 23596010102687

TWIST DRILL 3.5MM DIA 152.4MM LONG

Smith & Nephew, Inc.

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: 23596010102687
• NIH Device Record Key: 9d3f1462-1737-415e-8430-4f77872dc6d4
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 210451
• Catalog Number: 210451
• Company DUNS: 045483575
• Company Name: Smith & Nephew, Inc.
• 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)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	03596010102683 [Primary]
GS1	23596010102687 [Package]; Contains: 03596010102683; Package: BX [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093047

FDA Product Code

• KTT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

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

[23596010102687]

Moist Heat or Steam Sterilization

[23596010102687]

Moist Heat or Steam Sterilization

[23596010102687]

Moist Heat or Steam Sterilization

[23596010102687]

Moist Heat or Steam Sterilization

[23596010102687]

Moist Heat or Steam Sterilization

[23596010102687]

Moist Heat or Steam Sterilization

[23596010102687]

Moist Heat or Steam Sterilization

[23596010102687]

Moist Heat or Steam Sterilization

[23596010102687]

Moist Heat or Steam Sterilization

[23596010102687]

Moist Heat or Steam Sterilization

[23596010102687]

Moist Heat or Steam Sterilization

[23596010102687]

Moist Heat or Steam Sterilization

[23596010102687]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2023-09-07
• Device Publish Date: 2015-08-29

Devices Manufactured by Smith & Nephew, Inc.

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• 00885556902721 - INTELLIO SHIFT: 2024-05-21 NEO CONTROLLER SERVICE
• 00885556918562 - R3: 2024-05-21 R3 CONSTRAINED LINER 48MM
• 00885556918579 - TRIGEN: 2024-05-21 SHORT METATAN 10MM X 20CM LEFT
• 00885556918593 - TRIGEN: 2024-05-21 SHORT METATAN 10MM X 20CM LEFT
• 00885556918609 - TRIGEN: 2024-05-21 SHORT METATAN 10MM X 20CM RIGHT
• 00885556805015 - INTELLIO SHIFT: 2024-05-17 INTELLIO SHIFT Wired Foot Pedal