Biomet OrthoPak Non-invasive Bone Growth Stimulator System 1067718

GUDID 00812301020232

ORTHOPAK ASSEMBLY

EBI, LLC

Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator

• Primary Device ID: 00812301020232
• NIH Device Record Key: ad3153d8-6896-42f6-871f-4bc5aadd3a28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biomet OrthoPak Non-invasive Bone Growth Stimulator System
• Version Model Number: 1067718
• Catalog Number: 1067718
• Company DUNS: 050410323
• Company Name: EBI, 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: false
• Serial Number: true
• Manufacturing Date: true
• 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: 1.973.299.9300
• Email: btbs.csorders@biomet.com
• Phone: 1.973.299.9300
• Email: btbs.csorders@biomet.com
• Phone: 1.973.299.9300
• Email: btbs.csorders@biomet.com
• Phone: 1.973.299.9300
• Email: btbs.csorders@biomet.com
• Phone: 1.973.299.9300
• Email: btbs.csorders@biomet.com
• Phone: 1.973.299.9300
• Email: btbs.csorders@biomet.com
• Phone: 1.973.299.9300
• Email: btbs.csorders@biomet.com
• Phone: 1.973.299.9300
• Email: btbs.csorders@biomet.com
• Phone: 1.973.299.9300
• Email: btbs.csorders@biomet.com
• Phone: 1.973.299.9300
• Email: btbs.csorders@biomet.com
• Phone: 1.973.299.9300
• Email: btbs.csorders@biomet.com
• Phone: 1.973.299.9300
• Email: btbs.csorders@biomet.com
• Phone: 1.973.299.9300
• Email: btbs.csorders@biomet.com
• Phone: 1.973.299.9300
• Email: btbs.csorders@biomet.com
• Phone: 1.973.299.9300
• Email: btbs.csorders@biomet.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 100 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 100 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 100 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 100 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 100 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 100 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 100 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 100 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 100 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 100 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 100 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 100 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 100 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812301020232 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P850022

FDA Product Code

• LOF: Stimulator, Bone Growth, Non-Invasive

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-19

On-Brand Devices [Biomet OrthoPak Non-invasive Bone Growth Stimulator System]

• 00812301020355: ORTHOPAK ASSEMBLY - ROW
• 00812301020249: ORTHOPAK STIMULATOR, BIOMET
• 00812301020232: ORTHOPAK ASSEMBLY
• 00887868269318: 1067718-72
• 00887868269301: 1067718-63
• 00887868269295: 1067718-45