71364003

GUDID 03596010199195

BOX OSTEOTOME LARGE

Smith & Nephew, Inc.

Orthopaedic osteotome

• Primary Device ID: 03596010199195
• NIH Device Record Key: 3aaf9508-88c6-487f-a836-6ff810047e5d
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 71364003
• Catalog Number: 71364003
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03596010199195 [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

[03596010199195]

Moist Heat or Steam Sterilization

[03596010199195]

Moist Heat or Steam Sterilization

[03596010199195]

Moist Heat or Steam Sterilization

[03596010199195]

Moist Heat or Steam Sterilization

[03596010199195]

Moist Heat or Steam Sterilization

[03596010199195]

Moist Heat or Steam Sterilization

[03596010199195]

Moist Heat or Steam Sterilization

[03596010199195]

Moist Heat or Steam Sterilization

[03596010199195]

Moist Heat or Steam Sterilization

[03596010199195]

Moist Heat or Steam Sterilization

[03596010199195]

Moist Heat or Steam Sterilization

[03596010199195]

Moist Heat or Steam Sterilization

[03596010199195]

Moist Heat or Steam Sterilization

[03596010199195]

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: 2015-08-30

Devices Manufactured by Smith & Nephew, Inc.

• 00885556900260 - TRIGEN MAX: 2025-12-26 TRIGEN MAX BUTTRESS PLATE - TI
• 00885556898741 - INTERTAN MAX: 2025-12-24 INTERTAN MAX COMPRESSION SCREW 35MM
• 00885556721292 - N/A: 2025-12-23 GENERIC FULL TRAY LID
• 00885556746004 - SMART TSF: 2025-12-23 SMART TSF DYNAMIZATION KIT (6+6)
• 00885556917800 - EVOS: 2025-12-22 EVOS 3.5MM X 56MM CORTEX SCREW SELF-TAPPING
• 00885556917817 - EVOS: 2025-12-22 EVOS 3.5MM X 58MM CORTEX SCREW SELF-TAPPING
• 00885556917824 - EVOS: 2025-12-22 EVOS 3.5MM X 52MM LOCKING SCREW SELF-TAPPING
• 00885556917831 - EVOS: 2025-12-22 EVOS 3.5MM X 54MM LOCKING SCREW SELF-TAPPING