COMPREHENSIVE SHOULDER 110005273

GUDID 00880304568105

Biomet Orthopedics, LLC

Shoulder glenoid fossa prosthesis, prefabricated

• Primary Device ID: 00880304568105
• NIH Device Record Key: 31267950-4dd5-4fa2-a0bf-6451c664e9d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COMPREHENSIVE SHOULDER
• Version Model Number: 110005273
• Catalog Number: 110005273
• 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: 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)348-9500
• Email: customerservice@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304568105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130390

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-23
• Device Publish Date: 2015-10-24

On-Brand Devices [COMPREHENSIVE SHOULDER]

• 00880304568181: 110005302
• 00880304568174: 110005298
• 00880304568167: 110005294
• 00880304568150: 110005291
• 00880304568143: 110005287
• 00880304568136: 110005285
• 00880304568129: 110005283
• 00880304568112: 110005281
• 00880304568105: 110005273
• 00880304567955: 110005240
• 00880304567948: 110005237
• 00880304469563: 595505