REUNITE ORTHOPEDIC PIN SYSTEM 948231

GUDID 00880304564206

Biomet Orthopedics, LLC

Orthopaedic bone pin, bioabsorbable

• Primary Device ID: 00880304564206
• NIH Device Record Key: ab22c44b-82f0-4078-8eb9-062df20b74f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REUNITE ORTHOPEDIC PIN SYSTEM
• Version Model Number: 948231
• Catalog Number: 948231
• 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: 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
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 120 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304564206 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011522

FDA Product Code

• HTY: PIN, FIXATION, SMOOTH

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: 2015-12-04

On-Brand Devices [REUNITE ORTHOPEDIC PIN SYSTEM]

• 00880304564206: 948231
• 00880304564190: 948230
• 00880304424210: 948212