Comprehensive® Reverse Shoulder Instrument 406206

GUDID 00887868505126

Biomet Orthopedics, LLC

Surgical drill guide, reusable

• Primary Device ID: 00887868505126
• NIH Device Record Key: 35741bbd-a5e7-4c9a-a54f-da419660153e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Comprehensive® Reverse Shoulder Instrument
• Version Model Number: 406206
• Catalog Number: 406206
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	00887868505126 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120121

FDA Product Code

• PHX: shoulder prosthesis, reverse configuration

Sterilization

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

[00887868505126]

Moist Heat or Steam Sterilization

[00887868505126]

Moist Heat or Steam Sterilization

[00887868505126]

Moist Heat or Steam Sterilization

[00887868505126]

Moist Heat or Steam Sterilization

[00887868505126]

Moist Heat or Steam Sterilization

[00887868505126]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-30
• Device Publish Date: 2022-06-22

On-Brand Devices [Comprehensive® Reverse Shoulder Instrument]

• 00887868504600: 405809
• 00887868505119: 406205
• 00887868505140: 406209
• 00887868505133: 406207
• 00887868504808: 405909
• 00887868505126: 406206
• 00887868504785: 405907