Sirius® 31-149121

GUDID 00887868349591

Biomet Orthopedics, LLC

Femoral stem prosthesis trial

• Primary Device ID: 00887868349591
• NIH Device Record Key: 07164d95-e5ff-4caf-9bd3-a54135be3c94
• 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: false
• 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
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868349591 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142295

FDA Product Code

• KWL: Prosthesis, hip, hemi-, femoral, metal

Sterilization

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

[00887868349591]

Moist Heat or Steam Sterilization

[00887868349591]

Moist Heat or Steam Sterilization

[00887868349591]

Moist Heat or Steam Sterilization

[00887868349591]

Moist Heat or Steam Sterilization

[00887868349591]

Moist Heat or Steam Sterilization

[00887868349591]

Moist Heat or Steam Sterilization

[00887868349591]

Moist Heat or Steam Sterilization

[00887868349591]

Moist Heat or Steam Sterilization

[00887868349591]

Moist Heat or Steam Sterilization

[00887868349591]

Moist Heat or Steam Sterilization

[00887868349591]

Moist Heat or Steam Sterilization

[00887868349591]

Moist Heat or Steam Sterilization

[00887868349591]

Moist Heat or Steam Sterilization

[00887868349591]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-28
• Device Publish Date: 2020-12-19

On-Brand Devices [Sirius®]

• 00887868349782: 596045
• 00887868349768: 31-149164
• 00887868349751: 31-149163
• 00887868349744: 31-149161
• 00887868349737: 31-149160
• 00887868349720: 31-149137
• 00887868349713: 31-149136
• 00887868349706: 31-149135
• 00887868349690: 31-149134
• 00887868349683: 31-149133
• 00887868349676: 31-149132
• 00887868349669: 31-149131
• 00887868349652: 31-149127
• 00887868349645: 31-149126
• 00887868349638: 31-149125
• 00887868349621: 31-149124
• 00887868349614: 31-149123
• 00887868349607: 31-149122
• 00887868349591: 31-149121
• 00887868349577: 31-149110
• 00887868349560: 31-149107
• 00887868349553: 31-149106
• 00887868349546: 31-149105
• 00887868349539: 31-149104
• 00887868349522: 31-149103
• 00887868349515: 31-149102
• 00887868349508: 31-149101
• 00887868349584: 31-149115