VORTEX 71270084

GUDID 23596010457091

VORTEX AND MIXOR NOZZLE REVISION

Smith & Nephew, Inc.

Orthopaedic cement preparation/delivery kit

• Primary Device ID: 23596010457091
• NIH Device Record Key: d8a8571f-6bb7-436d-8b1f-03ae382790d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VORTEX
• Version Model Number: 71270084
• Catalog Number: 71270084
• Company DUNS: 045483575
• Company Name: Smith & Nephew, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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)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	03596010457097 [Primary]
GS1	23596010457091 [Package]; Contains: 03596010457097; Package: BX [5 Units]; In Commercial Distribution

FDA Product Code

• KIH: DISPENSER, 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: 3
• Public Version Date: 2023-09-07
• Device Publish Date: 2015-08-29

On-Brand Devices [VORTEX]

• 03596010457066: VORTEX ADAPTER
• 23596010457077: VORTEX AND MIXOR NOZZLE STANDARD BREAKWAY
• 03596010525550: VORTEX VACUUM BOWL
• 03596010515018: VORTEX CEMENT GUN
• 23596010464877: MIXOR AND VORTEX NOZZLE ANGLED
• 23596010457091: VORTEX AND MIXOR NOZZLE REVISION
• 23596010457084: VORTEX AND MIXOR NOZZLE LONG TAPERED
• 23596010456438: VORTEX AND MIXOR NOZZLE UMBRELLA
• 03596010456427: VORTEX RE-USE KIT
• 23596010453215: VORTEX VACUUM MIXING SYSTEM