210443

GUDID 23596010102601

TWIST DRILL 3.5MM DIA 127.0MM LONG

Smith & Nephew, Inc.

Fluted surgical drill bit, single-use

• Primary Device ID: 23596010102601
• NIH Device Record Key: efb6a689-59ad-4145-9e4d-ca8b32080323
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 210443
• Catalog Number: 210443
• 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	03596010102607 [Primary]
GS1	23596010102601 [Package]; Contains: 03596010102607; 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

[23596010102601]

Moist Heat or Steam Sterilization

[23596010102601]

Moist Heat or Steam Sterilization

[23596010102601]

Moist Heat or Steam Sterilization

[23596010102601]

Moist Heat or Steam Sterilization

[23596010102601]

Moist Heat or Steam Sterilization

[23596010102601]

Moist Heat or Steam Sterilization

[23596010102601]

Moist Heat or Steam Sterilization

[23596010102601]

Moist Heat or Steam Sterilization

[23596010102601]

Moist Heat or Steam Sterilization

[23596010102601]

Moist Heat or Steam Sterilization

[23596010102601]

Moist Heat or Steam Sterilization

[23596010102601]

Moist Heat or Steam Sterilization

[23596010102601]

Moist Heat or Steam Sterilization

[23596010102601]

Moist Heat or Steam Sterilization

[23596010102601]

Moist Heat or Steam Sterilization

[23596010102601]

Moist Heat or Steam Sterilization

[23596010102601]

Moist Heat or Steam Sterilization

[23596010102601]

Moist Heat or Steam Sterilization

[23596010102601]

Moist Heat or Steam Sterilization

[23596010102601]

Moist Heat or Steam Sterilization

[23596010102601]

Moist Heat or Steam Sterilization

[23596010102601]

Moist Heat or Steam Sterilization

[23596010102601]

Moist Heat or Steam Sterilization

[23596010102601]

Moist Heat or Steam Sterilization

[23596010102601]

Moist Heat or Steam Sterilization

[23596010102601]

Moist Heat or Steam Sterilization

[23596010102601]

Moist Heat or Steam Sterilization

[23596010102601]

Moist Heat or Steam Sterilization

[23596010102601]

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: 2015-08-29

Devices Manufactured by Smith & Nephew, Inc.

• 00885556921562 - LEGION: 2025-04-21 LEGION MEDIAL STABILIZED XLPE INSERT W/ JRNY LOCK RIGHT SZ 1-2 11MM
• 00885556921579 - LEGION: 2025-04-21 LEGION MEDIAL STABILIZED XLPE INSERT W/ JRNY LOCK RIGHT SZ 1-2 12MM
• 00885556921586 - LEGION: 2025-04-21 LEGION MEDIAL STABILIZED XLPE INSERT W/ JRNY LOCK RIGHT SZ 1-2 13MM
• 00885556921593 - LEGION: 2025-04-21 LEGION MEDIAL STABILIZED XLPE INSERT W/ JRNY LOCK RIGHT SZ 1-2 15MM
• 00885556921609 - LEGION: 2025-04-21 LEGION MEDIAL STABILIZED XLPE INSERT W/ JRNY LOCK RIGHT SZ 1-2 18MM
• 00885556921616 - LEGION: 2025-04-21 LEGION MEDIAL STABILIZED XLPE INSERT W/ JRNY LOCK RIGHT SZ 3-4 9MM
• 00885556921623 - LEGION: 2025-04-21 LEGION MEDIAL STABILIZED XLPE INSERT W/ JRNY LOCK RIGHT SZ 3-4 10MM
• 00885556921630 - LEGION: 2025-04-21 LEGION MEDIAL STABILIZED XLPE INSERT W/ JRNY LOCK RIGHT SZ 3-4 11MM