22MM THREAD CANNULATED CANCELLOUS SCREW 14196115

GUDID 00887868010132

Biomet Orthopedics, LLC

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

• Primary Device ID: 00887868010132
• NIH Device Record Key: 7d79df6a-4bbd-4999-bf68-5b8f62cd6815
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 22MM THREAD CANNULATED CANCELLOUS SCREW
• Version Model Number: 14196-115
• Catalog Number: 14196115
• 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: true
• 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
• 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 Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868010132 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111663

FDA Product Code

• LXT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE

Sterilization

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

[00887868010132]

Moist Heat or Steam Sterilization

[00887868010132]

Moist Heat or Steam Sterilization

[00887868010132]

Moist Heat or Steam Sterilization

[00887868010132]

Moist Heat or Steam Sterilization

[00887868010132]

Moist Heat or Steam Sterilization

[00887868010132]

Moist Heat or Steam Sterilization

[00887868010132]

Moist Heat or Steam Sterilization

[00887868010132]

Moist Heat or Steam Sterilization

[00887868010132]

Moist Heat or Steam Sterilization

[00887868010132]

Moist Heat or Steam Sterilization

[00887868010132]

Moist Heat or Steam Sterilization

[00887868010132]

Moist Heat or Steam Sterilization

[00887868010132]

Moist Heat or Steam Sterilization

[00887868010132]

Moist Heat or Steam Sterilization

[00887868010132]

Moist Heat or Steam Sterilization

[00887868010132]

Moist Heat or Steam Sterilization

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 [22MM THREAD CANNULATED CANCELLOUS SCREW]

• 00887868010149: 14196-120
• 00887868010132: 14196-115
• 00887868010125: 14196-110
• 00887868010118: 14196-105
• 00887868010101: 14196-100
• 00887868006746: 14196-95
• 00887868006739: 14196-90
• 00887868006722: 14196-85
• 00887868006715: 14196-80
• 00887868006708: 14196-75
• 00887868006692: 14196-70
• 00887868006685: 14196-65
• 00887868006678: 14196-60
• 00887868006661: 14196-55
• 00887868006654: 14196-50
• 00887868006647: 14196-45
• 00887868006630: 14196-40
• 00887868006623: 14196-35
• 00887868006616: 14196-30
• 00887868006609: 14196-25
• 00887868057175: 8514-65-120
• 00887868057168: 8514-65-115
• 00887868057151: 8514-65-110
• 00887868057144: 8514-65-105
• 00887868057137: 8514-65-100
• 00887868057120: 8514-65-095
• 00887868057113: 8514-65-090
• 00887868057106: 8514-65-085
• 00887868057090: 8514-65-080
• 00887868057083: 8514-65-075
• 00887868057076: 8514-65-070
• 00887868057069: 8514-65-065
• 00887868057052: 8514-65-060
• 00887868057045: 8514-65-055
• 00887868057038: 8514-65-050
• 00887868057021: 8514-65-045
• 00887868057014: 8514-65-040
• 00887868057007: 8514-65-035
• 00887868056994: 8514-65-030
• 00887868056987: 8514-65-025