EZLOC 904778

GUDID 00880304460447

Biomet Sports Medicine, LLC

Bone awl

• Primary Device ID: 00880304460447
• NIH Device Record Key: cd6c558a-ca3a-4fff-ae71-dbcc858e96a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EZLOC
• Version Model Number: 904778
• Catalog Number: 904778
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	00880304460447 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053461

FDA Product Code

• HWC: Screw, 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

On-Brand Devices [EZLOC]

• 00880304469969: 904779
• 00880304461307: 904777
• 00880304460447: 904778
• 00880304457362: 904789
• 00880304457355: 904788
• 00880304457348: 904785
• 00880304457331: 904784
• 00880304457324: 904781
• 00880304457317: 904780