210445

GUDID 03596010102621

TWIST DRILL 4.3MM DIA 127.0MM LONG

Smith & Nephew, Inc.

Fluted surgical drill bit, single-use

• Primary Device ID: 03596010102621
• NIH Device Record Key: f943a518-1801-451c-b5cb-b3a854a4df29
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 210445
• Catalog Number: 210445
• Company DUNS: 109903521
• 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: 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)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
• 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
• 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	03596010102621 [Primary]

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

[03596010102621]

Moist Heat or Steam Sterilization

[03596010102621]

Moist Heat or Steam Sterilization

[03596010102621]

Moist Heat or Steam Sterilization

[03596010102621]

Moist Heat or Steam Sterilization

[03596010102621]

Moist Heat or Steam Sterilization

[03596010102621]

Moist Heat or Steam Sterilization

[03596010102621]

Moist Heat or Steam Sterilization

[03596010102621]

Moist Heat or Steam Sterilization

[03596010102621]

Moist Heat or Steam Sterilization

[03596010102621]

Moist Heat or Steam Sterilization

[03596010102621]

Moist Heat or Steam Sterilization

[03596010102621]

Moist Heat or Steam Sterilization

[03596010102621]

Moist Heat or Steam Sterilization

[03596010102621]

Moist Heat or Steam Sterilization

[03596010102621]

Moist Heat or Steam Sterilization

[03596010102621]

Moist Heat or Steam Sterilization

[03596010102621]

Moist Heat or Steam Sterilization

[03596010102621]

Moist Heat or Steam Sterilization

[03596010102621]

Moist Heat or Steam Sterilization

[03596010102621]

Moist Heat or Steam Sterilization

[03596010102621]

Moist Heat or Steam Sterilization

[03596010102621]

Moist Heat or Steam Sterilization

[03596010102621]

Moist Heat or Steam Sterilization

[03596010102621]

Moist Heat or Steam Sterilization

[03596010102621]

Moist Heat or Steam Sterilization

[03596010102621]

Moist Heat or Steam Sterilization

[03596010102621]

Moist Heat or Steam Sterilization

[03596010102621]

Moist Heat or Steam Sterilization

[03596010102621]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-02-17
• Device Publish Date: 2015-08-25

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• 00885556921388 - Legion: 2024-12-04 Legion AP Cutting Block - Size 8
• 00885556921395 - Legion: 2024-12-04 Legion AP Cutting Block - Size 7
• 00885556921401 - Legion: 2024-12-04 Legion AP Cutting Block - Size 6
• 00885556921418 - Legion: 2024-12-04 Legion AP Cutting Block - Size 5