111716

GUDID 03596010039910

OSTEOTOME BLADE 12.5MM

Smith & Nephew, Inc.

Orthopaedic osteotome blade, reusable

• Primary Device ID: 03596010039910
• NIH Device Record Key: 7157be26-0c35-4325-9e3f-94b59a8eb169
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 111716
• Catalog Number: 111716
• 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: 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)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03596010039910 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121393

FDA Product Code

• HRY: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

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

[03596010039910]

Moist Heat or Steam Sterilization

[03596010039910]

Moist Heat or Steam Sterilization

[03596010039910]

Moist Heat or Steam Sterilization

[03596010039910]

Moist Heat or Steam Sterilization

[03596010039910]

Moist Heat or Steam Sterilization

[03596010039910]

Moist Heat or Steam Sterilization

[03596010039910]

Moist Heat or Steam Sterilization

[03596010039910]

Moist Heat or Steam Sterilization

[03596010039910]

Moist Heat or Steam Sterilization

[03596010039910]

Moist Heat or Steam Sterilization

[03596010039910]

Moist Heat or Steam Sterilization

[03596010039910]

Moist Heat or Steam Sterilization

[03596010039910]

Moist Heat or Steam Sterilization

[03596010039910]

Moist Heat or Steam Sterilization

[03596010039910]

Moist Heat or Steam Sterilization

[03596010039910]

Moist Heat or Steam Sterilization

[03596010039910]

Moist Heat or Steam Sterilization

[03596010039910]

Moist Heat or Steam Sterilization

[03596010039910]

Moist Heat or Steam Sterilization

[03596010039910]

Moist Heat or Steam Sterilization

[03596010039910]

Moist Heat or Steam Sterilization

[03596010039910]

Moist Heat or Steam Sterilization

[03596010039910]

Moist Heat or Steam Sterilization

[03596010039910]

Moist Heat or Steam Sterilization

[03596010039910]

Moist Heat or Steam Sterilization

[03596010039910]

Moist Heat or Steam Sterilization

[03596010039910]

Moist Heat or Steam Sterilization

[03596010039910]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-25

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• 00885556907245 - EVOS: 2025-10-01 EVOS PELVIC 3.5MM SYMPHYSIS NON-LOCKING PLATE STANDARD 6 HOLE
• 00885556907252 - EVOS: 2025-10-01 EVOS PELVIC 3.5MM SYMPHYSIS NON-LOCKING PLATE STANDARD 8 HOLE
• 00885556907290 - EVOS: 2025-10-01 EVOS PELVIC 2.7MM/3.5MM SYMPHYSIS LOCKING PLATE TABBED 4 HOLE