HYBRID GLENOID 113951

GUDID 00880304462472

Biomet Orthopedics, LLC

Shoulder glenoid fossa prosthesis, prefabricated

• Primary Device ID: 00880304462472
• NIH Device Record Key: b04c93a6-503c-4d32-a8ff-7c46fc77e0ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HYBRID GLENOID
• Version Model Number: 113951
• Catalog Number: 113951
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00880304462472 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060694

FDA Product Code

• KWT: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER 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 [HYBRID GLENOID]

• 00880304462625: 113952
• 00880304462618: 113956
• 00880304462489: 113954
• 00880304462472: 113951
• 00880304459854: PT-113950
• 00880304456600: 406152
• 00880304456587: 406151
• 00880304456570: 406182
• 00880304456457: 406181
• 00880304456365: 406150
• 00887868343865: 113951
• 00887868261169: SSI002443
• 00887868261152: SSI002442