Comprehensive® Prolong® 110031421

GUDID 00887868231520

Zimmer, Inc.

Polyethylene reverse shoulder prosthesis cup

• Primary Device ID: 00887868231520
• NIH Device Record Key: 8b223e14-b27b-454a-887f-afe9560b76ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Comprehensive® Prolong®
• Version Model Number: 110031421
• Catalog Number: 110031421
• 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	00887868231520 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181611

FDA Product Code

• PHX: shoulder prosthesis, reverse configuration

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® Prolong®]

• 00887868231544: 110031423
• 00887868231537: 110031422
• 00887868231520: 110031421
• 00887868231513: 110031420
• 00887868231506: 110031419
• 00887868231490: 110031418