WASHERLOC CP908834

GUDID 00880304117143

Biomet Sports Medicine, LLC

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00880304117143
• NIH Device Record Key: 89b059a2-aa67-40dd-ac1f-efab75cdafe5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WASHERLOC
• Version Model Number: CP908834
• Catalog Number: CP908834
• 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

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304117143 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981967

FDA Product Code

• MBI: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

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 [WASHERLOC]

• 00880304410244: 908469
• 00880304410237: 908468
• 00880304410060: 908434
• 00880304117204: CP908846
• 00880304117198: CP908844
• 00880304117181: CP908842
• 00880304117143: CP908834