BIO-MODULAR REVERSE SHOULDER 11-113680

GUDID 00880304591219

Biomet Orthopedics, LLC

Reverse shoulder prosthesis body

• Primary Device ID: 00880304591219
• NIH Device Record Key: bc312677-3b79-4677-8991-8f3340005e9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIO-MODULAR REVERSE SHOULDER
• Version Model Number: 11-113680
• Catalog Number: 11-113680
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	00880304591219 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093803

FDA Product Code

• KWS: PROSTHESIS, SHOULDER, SEMI-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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

On-Brand Devices [BIO-MODULAR REVERSE SHOULDER]

• 00880304591219: 11-113680
• 00880304506930: 11-113685
• 00880304562646: 595550