VERSABOND 71271340

GUDID 23596010494720

VERSABOND 40 GRAMS FORMULATION 2

Smith & Nephew, Inc.

Orthopaedic cement, non-medicated Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial

• Primary Device ID: 23596010494720
• NIH Device Record Key: c4ed3627-2f28-46c0-aab9-574191fa9dee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VERSABOND
• Version Model Number: 71271340
• Catalog Number: 71271340
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03596010494726 [Primary]
GS1	23596010494720 [Package]; Contains: 03596010494726; Package: BX [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033509

FDA Product Code

• LOD: BONE CEMENT

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-29

On-Brand Devices [VERSABOND]

• 23596010507376: VERSABOND AB 40 GRAMS FORMULATION 2
• 23596010494720: VERSABOND 40 GRAMS FORMULATION 2
• 23596010411024: VERSABOND 40 GRAMS