A.L.P.S. ELBOW SYSTEM DISTAL HUMERAL MEDIAL PLATE - RIGHT 131218705

GUDID 00887868013195

Biomet Orthopedics, LLC

Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 00887868013195
• NIH Device Record Key: 2ac0b132-92eb-40ae-93ab-90194c5f6c49
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: A.L.P.S. ELBOW SYSTEM DISTAL HUMERAL MEDIAL PLATE - RIGHT
• Version Model Number: 1312-18-705
• Catalog Number: 131218705
• 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	00887868013195 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101421

FDA Product Code

• HTN: WASHER, BOLT NUT

Sterilization

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

[00887868013195]

Moist Heat or Steam Sterilization

[00887868013195]

Moist Heat or Steam Sterilization

[00887868013195]

Moist Heat or Steam Sterilization

[00887868013195]

Moist Heat or Steam Sterilization

[00887868013195]

Moist Heat or Steam Sterilization

[00887868013195]

Moist Heat or Steam Sterilization

[00887868013195]

Moist Heat or Steam Sterilization

[00887868013195]

Moist Heat or Steam Sterilization

[00887868013195]

Moist Heat or Steam Sterilization

[00887868013195]

Moist Heat or Steam Sterilization

[00887868013195]

Moist Heat or Steam Sterilization

[00887868013195]

Moist Heat or Steam Sterilization

[00887868013195]

Moist Heat or Steam Sterilization

[00887868013195]

Moist Heat or Steam Sterilization

[00887868013195]

Moist Heat or Steam Sterilization

[00887868013195]

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 [A.L.P.S. ELBOW SYSTEM DISTAL HUMERAL MEDIAL PLATE - RIGHT]

• 00887868013195: 1312-18-705
• 00887868013188: 1312-18-704