210439

GUDID 23596010102564

TWIST DRILL 2.0MM DIA 127.0MM LONG

Smith & Nephew, Inc.

Fluted surgical drill bit, reusable

• Primary Device ID: 23596010102564
• NIH Device Record Key: 98c2235e-4525-4de7-a36f-835fe2183393
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 210439
• Catalog Number: 210439
• 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	03596010102560 [Primary]
GS1	23596010102564 [Package]; Contains: 03596010102560; 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

[23596010102564]

Moist Heat or Steam Sterilization

[23596010102564]

Moist Heat or Steam Sterilization

[23596010102564]

Moist Heat or Steam Sterilization

[23596010102564]

Moist Heat or Steam Sterilization

[23596010102564]

Moist Heat or Steam Sterilization

[23596010102564]

Moist Heat or Steam Sterilization

[23596010102564]

Moist Heat or Steam Sterilization

[23596010102564]

Moist Heat or Steam Sterilization

[23596010102564]

Moist Heat or Steam Sterilization

[23596010102564]

Moist Heat or Steam Sterilization

[23596010102564]

Moist Heat or Steam Sterilization

[23596010102564]

Moist Heat or Steam Sterilization

[23596010102564]

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.

• 00885556894279 - NA: 2025-05-23 TRIGEN MAX 0MM NAIL CAP
• 00885556894286 - NA: 2025-05-23 TRIGEN MAX 5MM NAIL CAP
• 00885556894293 - NA: 2025-05-23 TRIGEN MAX 10MM NAIL CAP
• 00885556894309 - NA: 2025-05-23 TRIGEN MAX 15MM NAIL CAP
• 00885556894316 - NA: 2025-05-23 TRIGEN MAX 20MM NAIL CAP
• 00885556895528 - TRIGEN MAX: 2025-05-22 TRIGEN MAX COMPRESSION SET SCREW (3.5MM HEX)
• 00885556892954 - TRIGEN MAX: 2025-05-20 TRIGEN MAX TIBIA NAIL 9MM X 29CM LEFT
• 00885556894552 - NA: 2025-05-20 TRIGEN MAX 5.0MM LOCKING SCREW - 77.5MM