INVIS 71313210

GUDID 03596010434630

INVIS DISTAL CENTRALIZER SIZE 10MM

Smith & Nephew, Inc.

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• Primary Device ID: 03596010434630
• NIH Device Record Key: 8f345154-cdc1-4210-946d-426b4445a050
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INVIS
• Version Model Number: 71313210
• Catalog Number: 71313210
• Company DUNS: 045483575
• 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)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	03596010434630 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K912593

FDA Product Code

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

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: 2023-09-07
• Device Publish Date: 2015-08-30

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• 03596010437518: INVIS DISTAL CENTRALIZERS SIZE 17MM
• 03596010437501: INVIS DISTAL CENTRALIZERS SIZE 16MM
• 03596010437495: INVIS DISTAL CENTRALIZERS SIZE 15MM
• 03596010437488: INVIS DISTAL CENTRALIZER SIZE 11MM
• 03596010435781: INVIS DISTAL CENTRALIZERS SIZE 13MM
• 03596010435736: INVIS DISTAL CENTRALIZERS SIZE 14MM
• 03596010435446: INVIS DISTAL CENTRALIZER SIZE 9MM
• 03596010434630: INVIS DISTAL CENTRALIZER SIZE 10MM
• 03596010432674: INVIS DISTAL CENTRALIZER SIZE 12MM
• 03596010427151: INVIS DISTAL CENTRALIZER SIZE 8MM