BIO-PHASE II 905502

GUDID 00880304007048

Biomet Sports Medicine, LLC

Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 00880304007048
• NIH Device Record Key: eec82c1c-af92-434e-ad0b-c9914030e0b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIO-PHASE II
• Version Model Number: 905502
• Catalog Number: 905502
• Company DUNS: 627100159
• Company Name: Biomet Sports Medicine, 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
• 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	00880304007048 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954443

FDA Product Code

• JDR: STAPLE, FIXATION, BONE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-03-21
• Device Publish Date: 2015-10-24

Devices Manufactured by Biomet Sports Medicine, LLC

• 00880304460454 - MAXFIRE: 2020-05-06
• 00880304475915 - MAXFIRE MARXMEN: 2020-05-06
• 00880304475922 - MAXFIRE MARXMEN: 2020-05-06
• 00880304477193 - JUGGERKNOT SOFT ANCHORS: 2020-02-06
• 00880304477315 - JUGGERKNOT SOFT ANCHORS: 2020-02-06
• 00880304508590 - JUGGERKNOT SOFT ANCHORS: 2020-02-06
• 00880304509627 - JUGGERKNOT SOFT ANCHORS: 2020-02-06
• 00880304511699 - JUGGERKNOT SOFT ANCHORS: 2020-02-06