PLUS-MIA E0014802-2

GUDID 00885556621837

PROXIMALLY OVERSIZED BROACH SIZE 5

Smith & Nephew, Inc.

Orthopaedic broach

• Primary Device ID: 00885556621837
• NIH Device Record Key: dfc3f9da-fa6d-45a6-b48d-c033fa8ab09f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PLUS-MIA
• Version Model Number: E0014802-2
• Catalog Number: E0014802-2
• 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
• 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	00885556621837 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123598

FDA Product Code

• JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented

Sterilization

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

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

[00885556621837]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-04-25

On-Brand Devices [PLUS-MIA]

• 00885556621851: PROXIMALLY OVERSIZED BROACH SIZE 6
• 00885556621844: PROXIMALLY OVERSIZED BROACH SIZE 7
• 00885556621837: PROXIMALLY OVERSIZED BROACH SIZE 5
• 00885556621820: PROXIMALLY OVERSIZED BROACH SIZE 4