Comprehensive® Vivacit-E® 110031428

GUDID 00887868231599

Zimmer, Inc.

Polyethylene reverse shoulder prosthesis cup

• Primary Device ID: 00887868231599
• NIH Device Record Key: 1a6572ff-3162-4212-889b-a8e8e375a946
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Comprehensive® Vivacit-E®
• Version Model Number: 110031428
• Catalog Number: 110031428
• Company DUNS: 056038268
• Company Name: Zimmer, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868231599 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181611

FDA Product Code

• PAO: prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-11
• Device Publish Date: 2019-02-22

On-Brand Devices [Comprehensive® Vivacit-E®]

• 00887868231575: 110031426
• 00887868231605: 110031429
• 00887868231599: 110031428
• 00887868231582: 110031427
• 00887868231568: 110031425
• 00887868231551: 110031424