PEG THREAD MULTIDIRECTIONAL 131211112

GUDID 00887868011306

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 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: 00887868011306
• NIH Device Record Key: a4237af6-2090-41dc-b6ae-f2e4ed5da0a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PEG THREAD MULTIDIRECTIONAL
• Version Model Number: 1312-11-112
• Catalog Number: 131211112
• 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
• 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
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• 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	00887868011306 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060864

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[00887868011306]

Moist Heat or Steam Sterilization

[00887868011306]

Moist Heat or Steam Sterilization

[00887868011306]

Moist Heat or Steam Sterilization

[00887868011306]

Moist Heat or Steam Sterilization

[00887868011306]

Moist Heat or Steam Sterilization

[00887868011306]

Moist Heat or Steam Sterilization

[00887868011306]

Moist Heat or Steam Sterilization

[00887868011306]

Moist Heat or Steam Sterilization

[00887868011306]

Moist Heat or Steam Sterilization

[00887868011306]

Moist Heat or Steam Sterilization

[00887868011306]

Moist Heat or Steam Sterilization

[00887868011306]

Moist Heat or Steam Sterilization

[00887868011306]

Moist Heat or Steam Sterilization

[00887868011306]

Moist Heat or Steam Sterilization

[00887868011306]

Moist Heat or Steam Sterilization

[00887868011306]

Moist Heat or Steam Sterilization

[00887868011306]

Moist Heat or Steam Sterilization

[00887868011306]

Moist Heat or Steam Sterilization

[00887868011306]

Moist Heat or Steam Sterilization

[00887868011306]

Moist Heat or Steam Sterilization

[00887868011306]

Moist Heat or Steam Sterilization

[00887868011306]

Moist Heat or Steam Sterilization

[00887868011306]

Moist Heat or Steam Sterilization

[00887868011306]

Moist Heat or Steam Sterilization

[00887868011306]

Moist Heat or Steam Sterilization

[00887868011306]

Moist Heat or Steam Sterilization

[00887868011306]

Moist Heat or Steam Sterilization

[00887868011306]

Moist Heat or Steam Sterilization

[00887868011306]

Moist Heat or Steam Sterilization

[00887868011306]

Moist Heat or Steam Sterilization

[00887868011306]

Moist Heat or Steam Sterilization

[00887868011306]

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 [PEG THREAD MULTIDIRECTIONAL]

• 00887868011412: 1312-11-130
• 00887868011405: 1312-11-128
• 00887868011399: 1312-11-126
• 00887868011382: 1312-11-124
• 00887868011375: 1312-11-122
• 00887868011368: 1312-11-120
• 00887868011351: 1312-11-118
• 00887868011344: 1312-11-116
• 00887868011320: 1312-11-114
• 00887868011306: 1312-11-112
• 00887868011283: 1312-11-110