PE.R.I.™LOWER EXT PLATE, FIBULA COMPOSITE 814123009

GUDID 00887868036828

Biomet Orthopedics, LLC

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 Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 00887868036828
• NIH Device Record Key: ba642c36-fcc0-4c67-9191-24f9ae8abc63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PE.R.I.™LOWER EXT PLATE, FIBULA COMPOSITE
• Version Model Number: 8141-23-009
• Catalog Number: 814123009
• 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	00887868036828 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083843

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

[00887868036828]

Moist Heat or Steam Sterilization

[00887868036828]

Moist Heat or Steam Sterilization

[00887868036828]

Moist Heat or Steam Sterilization

[00887868036828]

Moist Heat or Steam Sterilization

[00887868036828]

Moist Heat or Steam Sterilization

[00887868036828]

Moist Heat or Steam Sterilization

[00887868036828]

Moist Heat or Steam Sterilization

[00887868036828]

Moist Heat or Steam Sterilization

[00887868036828]

Moist Heat or Steam Sterilization

[00887868036828]

Moist Heat or Steam Sterilization

[00887868036828]

Moist Heat or Steam Sterilization

[00887868036828]

Moist Heat or Steam Sterilization

[00887868036828]

Moist Heat or Steam Sterilization

[00887868036828]

Moist Heat or Steam Sterilization

[00887868036828]

Moist Heat or Steam Sterilization

[00887868036828]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-15
• Device Publish Date: 2017-03-17

On-Brand Devices [PE.R.I.™LOWER EXT PLATE, FIBULA COMPOSITE]

• 00887868036873: 8141-23-014
• 00887868036866: 8141-23-013
• 00887868036859: 8141-23-012
• 00887868036842: 8141-23-011
• 00887868036835: 8141-23-010
• 00887868036828: 8141-23-009
• 00887868036811: 8141-23-008
• 00887868036804: 8141-23-007
• 00887868036798: 8141-23-006
• 00887868036781: 8141-23-005