SIRIUS 31-149121

GUDID 00880304543867

Biomet Orthopedics, LLC

Femoral stem prosthesis trial

• Primary Device ID: 00880304543867
• NIH Device Record Key: a94cfc15-51ba-4e26-868c-7979409c02e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIRIUS
• Version Model Number: 31-149121
• Catalog Number: 31-149121
• 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: true
• 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

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304543867 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142295

FDA Product Code

• JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented

Sterilization

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

[00880304543867]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-10-28

On-Brand Devices [SIRIUS]

• 00880304681972: 31-149165
• 00880304672970: 31-149164
• 00880304672956: 31-149110
• 00880304672949: 31-149115
• 00880304543928: 31-149104
• 00880304543911: 31-149160
• 00880304543904: 31-149125
• 00880304543898: 31-149124
• 00880304543881: 31-149122
• 00880304543874: 31-149126
• 00880304543867: 31-149121
• 00880304543850: 31-149123
• 00880304543843: 31-149106
• 00880304543836: 31-149127
• 00880304543829: 31-149161
• 00880304543812: 31-149134
• 00880304543805: 31-149101
• 00880304543799: 31-149133
• 00880304543782: 31-149135
• 00880304543775: 31-149131
• 00880304543768: 31-149102
• 00880304543751: 31-149132
• 00880304543744: 31-149103
• 00880304543737: 31-149107
• 00880304543720: 31-149136
• 00880304543713: 31-149105
• 00880304543706: 31-149137
• 00880304543690: 31-149163