CALANDRUCCIO II COMPRESSION DEVICE 71040005

GUDID 03596010430069

TROCAR

Smith & Nephew, Inc.

Orthopaedic trocar blade, reusable Orthopaedic trocar blade, reusable Orthopaedic trocar blade, reusable Orthopaedic trocar blade, reusable Orthopaedic trocar blade, reusable Orthopaedic trocar blade, reusable Orthopaedic trocar blade, reusable Orthopaedic trocar blade, reusable Orthopaedic trocar blade, reusable Orthopaedic trocar blade, reusable Orthopaedic trocar blade, reusable Orthopaedic trocar blade, reusable Orthopaedic trocar blade, reusable Orthopaedic trocar blade, reusable Orthopaedic trocar blade, reusable Orthopaedic trocar blade, reusable Orthopaedic trocar blade, reusable Orthopaedic trocar blade, reusable Orthopaedic trocar blade, reusable Orthopaedic trocar blade, reusable Orthopaedic trocar blade, reusable Orthopaedic trocar blade, reusable Orthopaedic trocar blade, reusable Orthopaedic trocar blade, reusable Orthopaedic trocar blade, reusable Orthopaedic trocar blade, reusable Orthopaedic trocar blade, reusable Orthopaedic trocar blade, reusable

• Primary Device ID: 03596010430069
• NIH Device Record Key: fdf808e6-4a4b-48c7-b550-749de62b00c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CALANDRUCCIO II COMPRESSION DEVICE
• Version Model Number: 71040005
• Catalog Number: 71040005
• 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	03596010430069 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120871

FDA Product Code

• JDW: PIN, FIXATION, THREADED

Sterilization

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

[03596010430069]

Moist Heat or Steam Sterilization

[03596010430069]

Moist Heat or Steam Sterilization

[03596010430069]

Moist Heat or Steam Sterilization

[03596010430069]

Moist Heat or Steam Sterilization

[03596010430069]

Moist Heat or Steam Sterilization

[03596010430069]

Moist Heat or Steam Sterilization

[03596010430069]

Moist Heat or Steam Sterilization

[03596010430069]

Moist Heat or Steam Sterilization

[03596010430069]

Moist Heat or Steam Sterilization

[03596010430069]

Moist Heat or Steam Sterilization

[03596010430069]

Moist Heat or Steam Sterilization

[03596010430069]

Moist Heat or Steam Sterilization

[03596010430069]

Moist Heat or Steam Sterilization

[03596010430069]

Moist Heat or Steam Sterilization

[03596010430069]

Moist Heat or Steam Sterilization

[03596010430069]

Moist Heat or Steam Sterilization

[03596010430069]

Moist Heat or Steam Sterilization

[03596010430069]

Moist Heat or Steam Sterilization

[03596010430069]

Moist Heat or Steam Sterilization

[03596010430069]

Moist Heat or Steam Sterilization

[03596010430069]

Moist Heat or Steam Sterilization

[03596010430069]

Moist Heat or Steam Sterilization

[03596010430069]

Moist Heat or Steam Sterilization

[03596010430069]

Moist Heat or Steam Sterilization

[03596010430069]

Moist Heat or Steam Sterilization

[03596010430069]

Moist Heat or Steam Sterilization

[03596010430069]

Moist Heat or Steam Sterilization

[03596010430069]

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

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• 00885556817667 - TULA: 2024-05-07 TULA KIT- UNILATERAL (NST007068)
• 00885556890745 - Q-FIX: 2024-05-06 Q-FIX ULTRA
• 00885556890752 - ULTRABRACE: 2024-05-06 ULTRABRACE KIT
• 00885556890769 - FOOTPRINT: 2024-05-06 FOOTPRINT MINI PK 3.5MM