CALANDRUCCIO II 71040008

GUDID 03596010171559

CALANDRUCCIO II RADIOLUCENT PIN GUIDE

Smith & Nephew, Inc.

External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable

• Primary Device ID: 03596010171559
• NIH Device Record Key: ec53cd28-16e3-4c5f-9b71-764f44b391ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CALANDRUCCIO II
• Version Model Number: 71040008
• Catalog Number: 71040008
• 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)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	03596010171559 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122170

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

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

[03596010171559]

Moist Heat or Steam Sterilization

[03596010171559]

Moist Heat or Steam Sterilization

[03596010171559]

Moist Heat or Steam Sterilization

[03596010171559]

Moist Heat or Steam Sterilization

[03596010171559]

Moist Heat or Steam Sterilization

[03596010171559]

Moist Heat or Steam Sterilization

[03596010171559]

Moist Heat or Steam Sterilization

[03596010171559]

Moist Heat or Steam Sterilization

[03596010171559]

Moist Heat or Steam Sterilization

[03596010171559]

Moist Heat or Steam Sterilization

[03596010171559]

Moist Heat or Steam Sterilization

[03596010171559]

Moist Heat or Steam Sterilization

[03596010171559]

Moist Heat or Steam Sterilization

[03596010171559]

Moist Heat or Steam Sterilization

[03596010171559]

Moist Heat or Steam Sterilization

[03596010171559]

Moist Heat or Steam Sterilization

[03596010171559]

Moist Heat or Steam Sterilization

[03596010171559]

Moist Heat or Steam Sterilization

[03596010171559]

Moist Heat or Steam Sterilization

[03596010171559]

Moist Heat or Steam Sterilization

[03596010171559]

Moist Heat or Steam Sterilization

[03596010171559]

Moist Heat or Steam Sterilization

[03596010171559]

Moist Heat or Steam Sterilization

[03596010171559]

Moist Heat or Steam Sterilization

[03596010171559]

Moist Heat or Steam Sterilization

[03596010171559]

Moist Heat or Steam Sterilization

[03596010171559]

Moist Heat or Steam Sterilization

[03596010171559]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-11-03
• Device Publish Date: 2015-08-25

On-Brand Devices [CALANDRUCCIO II]

• 23596010413356: 5IN CALANDRUCCIO II COMPRESSION BOLT
• 03596010410399: CALANDRUCCIO II PIN SLEEVE
• 03596010171559: CALANDRUCCIO II RADIOLUCENT PIN GUIDE
• 23596010171492: 4IN CALANDRUCCIO II COMPRESSION BOLT
• 03596010171481: CALANDRUCCIO II COMPRESSION CLAMP