210438

GUDID 23596010102557

TWIST DRILL 1.6MM DIA 127.0MM 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 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 Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable

• Primary Device ID: 23596010102557
• NIH Device Record Key: 03af5a34-f4b3-45fa-9bbc-806bb60d9905
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 210438
• Catalog Number: 210438
• Company DUNS: 109903521
• Company Name: Smith & Nephew, Inc.
• Device Count: 6
• DM Exempt: true
• 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
• 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	03596010102553 [Unit of Use]
GS1	23596010102557 [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

[23596010102557]

Moist Heat or Steam Sterilization

[23596010102557]

Moist Heat or Steam Sterilization

[23596010102557]

Moist Heat or Steam Sterilization

[23596010102557]

Moist Heat or Steam Sterilization

[23596010102557]

Moist Heat or Steam Sterilization

[23596010102557]

Moist Heat or Steam Sterilization

[23596010102557]

Moist Heat or Steam Sterilization

[23596010102557]

Moist Heat or Steam Sterilization

[23596010102557]

Moist Heat or Steam Sterilization

[23596010102557]

Moist Heat or Steam Sterilization

[23596010102557]

Moist Heat or Steam Sterilization

[23596010102557]

Moist Heat or Steam Sterilization

[23596010102557]

Moist Heat or Steam Sterilization

[23596010102557]

Moist Heat or Steam Sterilization

[23596010102557]

Moist Heat or Steam Sterilization

[23596010102557]

Moist Heat or Steam Sterilization

[23596010102557]

Moist Heat or Steam Sterilization

[23596010102557]

Moist Heat or Steam Sterilization

[23596010102557]

Moist Heat or Steam Sterilization

[23596010102557]

Moist Heat or Steam Sterilization

[23596010102557]

Moist Heat or Steam Sterilization

[23596010102557]

Moist Heat or Steam Sterilization

[23596010102557]

Moist Heat or Steam Sterilization

[23596010102557]

Moist Heat or Steam Sterilization

[23596010102557]

Moist Heat or Steam Sterilization

[23596010102557]

Moist Heat or Steam Sterilization

[23596010102557]

Moist Heat or Steam Sterilization

[23596010102557]

Moist Heat or Steam Sterilization

[23596010102557]

Moist Heat or Steam Sterilization

[23596010102557]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2023-08-04
• Device Publish Date: 2015-08-29

Devices Manufactured by Smith & Nephew, Inc.

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• 00885556630761 - Q-FIX: 2024-05-14 DISPOSABLE 1.8MM Q-FIX DRILL
• 00885556630785 - Q-FIX: 2024-05-14 REUSABLE 1.8MMQ-FIX DRILL GUIDE
• 00885556918333 - R3: 2024-05-10 FEMORAL OSTEOTOMY RULER
• 00885556817667 - TULA: 2024-05-07 TULA KIT- UNILATERAL (NST007068)
• 00885556890745 - Q-FIX: 2024-05-06 Q-FIX ULTRA
• 00885556890752 - ULTRABRACE: 2024-05-06 ULTRABRACE KIT
• 00885556890769 - FOOTPRINT: 2024-05-06 FOOTPRINT MINI PK 3.5MM