Comprehensive® Revision Shoulder System 407354

GUDID 00887868506024

Biomet Orthopedics, LLC

Humeral stem prosthesis trial

• Primary Device ID: 00887868506024
• NIH Device Record Key: fcc358b2-6160-42fa-8987-d5df838b9489
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Comprehensive® Revision Shoulder System
• Version Model Number: 407354
• Catalog Number: 407354
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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 Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868506024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060692

FDA Product Code

• HSD: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Sterilization

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

[00887868506024]

Moist Heat or Steam Sterilization

[00887868506024]

Moist Heat or Steam Sterilization

[00887868506024]

Moist Heat or Steam Sterilization

[00887868506024]

Moist Heat or Steam Sterilization

[00887868506024]

Moist Heat or Steam Sterilization

[00887868506024]

Moist Heat or Steam Sterilization

[00887868506024]

Moist Heat or Steam Sterilization

[00887868506024]

Moist Heat or Steam Sterilization

[00887868506024]

Moist Heat or Steam Sterilization

[00887868506024]

Moist Heat or Steam Sterilization

[00887868506024]

Moist Heat or Steam Sterilization

[00887868506024]

Moist Heat or Steam Sterilization

[00887868506024]

Moist Heat or Steam Sterilization

[00887868506024]

Moist Heat or Steam Sterilization

[00887868506024]

Moist Heat or Steam Sterilization

[00887868506024]

Moist Heat or Steam Sterilization

[00887868506024]

Moist Heat or Steam Sterilization

[00887868506024]

Moist Heat or Steam Sterilization

[00887868506024]

Moist Heat or Steam Sterilization

[00887868506024]

Moist Heat or Steam Sterilization

[00887868506024]

Moist Heat or Steam Sterilization

[00887868506024]

Moist Heat or Steam Sterilization

[00887868506024]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-02
• Device Publish Date: 2022-04-23

On-Brand Devices [Comprehensive® Revision Shoulder System]

• 00887868506024: 407354
• 00887868506017: 407352
• 00887868506000: 407350
• 00887868505997: 407348
• 00887868505973: 407344