Bio-Modular® Reverse Shoulder 11-113685

GUDID 00887868254062

Biomet Orthopedics, LLC

Reverse shoulder prosthesis body

• Primary Device ID: 00887868254062
• NIH Device Record Key: dcce7070-6f92-4eac-8c71-2916cb5bf133
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bio-Modular® Reverse Shoulder
• Version Model Number: 11-113685
• Catalog Number: 11-113685
• 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	00887868254062 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-08-23
• Device Publish Date: 2018-07-23

Devices Manufactured by Biomet Orthopedics, LLC

• 00887868254451 - Comprehensive® Reverse Shoulder: 2024-11-21
• 00887868578250 - Comprehensive®: 2024-11-13
• 08428898885684 - BIPASS DISPOSABLE PUSHER: 2024-09-11
• 08428898885691 - BIPASS DISPOSABLE PUSHER: 2024-09-11
• 00880304338548 - AGC ANTERIOR FILE: 2024-09-11
• 00880304339224 - PARALLEL PULLER: 2024-09-11
• 00880304342187 - AGC MODULAR TIBIAL II: 2024-09-11
• 00880304365247 - BIO-MODULAR: 2024-09-11