71364004

GUDID 03596010199201

CALCAR REAMER SMALL

Smith & Nephew, Inc.

Bone-resection orthopaedic reamer, reusable

• Primary Device ID: 03596010199201
• NIH Device Record Key: ab0bf12c-e5b8-4685-ae81-2e0c624a4a22
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 71364004
• Catalog Number: 71364004
• 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
• 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
• 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	03596010199201 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123598

FDA Product Code

• JDG: Prosthesis, hip, femoral component, cemented, metal

Sterilization

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

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

[03596010199201]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-30

Devices Manufactured by Smith & Nephew, Inc.

• 00885556892954 - TRIGEN MAX: 2025-05-20 TRIGEN MAX TIBIA NAIL 9MM X 29CM LEFT
• 00885556894552 - NA: 2025-05-20 TRIGEN MAX 5.0MM LOCKING SCREW - 77.5MM
• 00885556896662 - NA: 2025-05-20 TRIGEN MAX 5.0MM LAG SCREW - 77.5MM
• 00885556892596 - TRIGEN MAX: 2025-05-19 TRIGEN MAX TIBIA NAIL 8MM X 34CM LEFT
• 00885556892619 - TRIGEN MAX: 2025-05-19 TRIGEN MAX TIBIA NAIL 8MM X 36CM LEFT
• 00885556892626 - TRIGEN MAX: 2025-05-19 TRIGEN MAX TIBIA NAIL 8MM X 37CM LEFT
• 00885556892633 - TRIGEN MAX: 2025-05-19 TRIGEN MAX TIBIA NAIL 8MM X 38CM LEFT
• 00885556892640 - TRIGEN MAX: 2025-05-19 TRIGEN MAX TIBIA NAIL 8MM X 39CM LEFT