CALANDRUCCIO II 71040002

GUDID 23596010171492

4IN CALANDRUCCIO II COMPRESSION BOLT

Smith & Nephew, Inc.

External orthopaedic fixation system, reusable

• Primary Device ID: 23596010171492
• NIH Device Record Key: a5c94f0a-f063-45ad-8031-c76caca5fbcd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CALANDRUCCIO II
• Version Model Number: 71040002
• Catalog Number: 71040002
• 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	03596010171498 [Primary]
GS1	23596010171492 [Package]; Contains: 03596010171498; Package: BX [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K994143

FDA Product Code

• JDW: PIN, FIXATION, THREADED

Sterilization

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

[23596010171492]

Moist Heat or Steam Sterilization

[23596010171492]

Moist Heat or Steam Sterilization

[23596010171492]

Moist Heat or Steam Sterilization

[23596010171492]

Moist Heat or Steam Sterilization

[23596010171492]

Moist Heat or Steam Sterilization

[23596010171492]

Moist Heat or Steam Sterilization

[23596010171492]

Moist Heat or Steam Sterilization

[23596010171492]

Moist Heat or Steam Sterilization

[23596010171492]

Moist Heat or Steam Sterilization

[23596010171492]

Moist Heat or Steam Sterilization

[23596010171492]

Moist Heat or Steam Sterilization

[23596010171492]

Moist Heat or Steam Sterilization

[23596010171492]

Moist Heat or Steam Sterilization

[23596010171492]

Moist Heat or Steam Sterilization

[23596010171492]

Moist Heat or Steam Sterilization

[23596010171492]

Moist Heat or Steam Sterilization

[23596010171492]

Moist Heat or Steam Sterilization

[23596010171492]

Moist Heat or Steam Sterilization

[23596010171492]

Moist Heat or Steam Sterilization

[23596010171492]

Moist Heat or Steam Sterilization

[23596010171492]

Moist Heat or Steam Sterilization

[23596010171492]

Moist Heat or Steam Sterilization

[23596010171492]

Moist Heat or Steam Sterilization

[23596010171492]

Moist Heat or Steam Sterilization

[23596010171492]

Moist Heat or Steam Sterilization

[23596010171492]

Moist Heat or Steam Sterilization

[23596010171492]

Moist Heat or Steam Sterilization

[23596010171492]

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: 2015-08-29

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