CALANDRUCCIO II 71040008

GUDID 03596010171559

CALANDRUCCIO II RADIOLUCENT PIN GUIDE

Smith & Nephew, Inc.

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