Comprehensive® Shoulder 110005285

GUDID 00887868348495

Biomet Orthopedics, LLC

Humeral head prosthesis trial, reusable Humeral head prosthesis trial, reusable Humeral head prosthesis trial, reusable

• Primary Device ID: 00887868348495
• NIH Device Record Key: b7211d22-f11f-4234-8efd-76f60761efd6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Comprehensive® Shoulder
• Version Model Number: 110005285
• Catalog Number: 110005285
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868348495 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130390

FDA Product Code

• PHX: shoulder prosthesis, reverse configuration

Sterilization

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

[00887868348495]

Moist Heat or Steam Sterilization

[00887868348495]

Moist Heat or Steam Sterilization

[00887868348495]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-18
• Device Publish Date: 2020-05-08

On-Brand Devices [Comprehensive® Shoulder]

• 00887868343797: 110005273
• 00887868343780: 110005237
• 00887868348549: 110005302
• 00887868348525: 110005294
• 00887868348518: 110005291
• 00887868348501: 110005287
• 00887868348495: 110005285
• 00887868348488: 110005283
• 00887868348471: 110005281