71161065

GUDID 03596010301840

TITANIUM CANNULATED SCREW 6.5MM X 65MM

Smith & Nephew, Inc.

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 03596010301840
• NIH Device Record Key: 6ffab4ad-f557-4688-8fb8-972cd9043b73
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 71161065
• Catalog Number: 71161065
• Company DUNS: 109903521
• Company Name: Smith & Nephew, Inc.
• Device Count: 1
• 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: 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
• 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	03596010301840 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210837
• Premarket Notification: K993289

FDA Product Code

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

Sterilization

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

[03596010301840]

Moist Heat or Steam Sterilization

[03596010301840]

Moist Heat or Steam Sterilization

[03596010301840]

Moist Heat or Steam Sterilization

[03596010301840]

Moist Heat or Steam Sterilization

[03596010301840]

Moist Heat or Steam Sterilization

[03596010301840]

Moist Heat or Steam Sterilization

[03596010301840]

Moist Heat or Steam Sterilization

[03596010301840]

Moist Heat or Steam Sterilization

[03596010301840]

Moist Heat or Steam Sterilization

[03596010301840]

Moist Heat or Steam Sterilization

[03596010301840]

Moist Heat or Steam Sterilization

[03596010301840]

Moist Heat or Steam Sterilization

[03596010301840]

Moist Heat or Steam Sterilization

[03596010301840]

Moist Heat or Steam Sterilization

[03596010301840]

Moist Heat or Steam Sterilization

[03596010301840]

Moist Heat or Steam Sterilization

[03596010301840]

Moist Heat or Steam Sterilization

[03596010301840]

Moist Heat or Steam Sterilization

[03596010301840]

Moist Heat or Steam Sterilization

[03596010301840]

Moist Heat or Steam Sterilization

[03596010301840]

Moist Heat or Steam Sterilization

[03596010301840]

Moist Heat or Steam Sterilization

[03596010301840]

Moist Heat or Steam Sterilization

[03596010301840]

Moist Heat or Steam Sterilization

[03596010301840]

Moist Heat or Steam Sterilization

[03596010301840]

Moist Heat or Steam Sterilization

[03596010301840]

Moist Heat or Steam Sterilization

[03596010301840]

Moist Heat or Steam Sterilization

[03596010301840]

Moist Heat or Steam Sterilization

[03596010301840]

Moist Heat or Steam Sterilization

[03596010301840]

Moist Heat or Steam Sterilization

[03596010301840]

Moist Heat or Steam Sterilization

[03596010301840]

Moist Heat or Steam Sterilization

[03596010301840]

Moist Heat or Steam Sterilization

[03596010301840]

Moist Heat or Steam Sterilization

[03596010301840]

Moist Heat or Steam Sterilization

[03596010301840]

Moist Heat or Steam Sterilization

[03596010301840]

Moist Heat or Steam Sterilization

[03596010301840]

Moist Heat or Steam Sterilization

[03596010301840]

Moist Heat or Steam Sterilization

[03596010301840]

Moist Heat or Steam Sterilization

[03596010301840]

Moist Heat or Steam Sterilization

[03596010301840]

Moist Heat or Steam Sterilization

[03596010301840]

Moist Heat or Steam Sterilization

[03596010301840]

Moist Heat or Steam Sterilization

[03596010301840]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-10-22
• Device Publish Date: 2015-08-25

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• 00885556892534 - TRIGEN MAX: 2025-05-16 TRIGEN MAX TIBIA NAIL 8MM X 28CM LEFT
• 00885556892541 - TRIGEN MAX: 2025-05-16 TRIGEN MAX TIBIA NAIL 8MM X 29CM LEFT
• 00885556892558 - TRIGEN MAX: 2025-05-16 TRIGEN MAX TIBIA NAIL 8MM X 30CM LEFT
• 00885556892565 - TRIGEN MAX: 2025-05-16 TRIGEN MAX TIBIA NAIL 8MM X 31CM LEFT