Biomet EBI Bone Healing System 1068240

GUDID 00812301020621

SFLX - XL COILETTE

EBI, LLC

Patient-worn bone growth electromagnetic stimulator

• Primary Device ID: 00812301020621
• NIH Device Record Key: 3884e0d4-f0ac-4800-89b3-6fac02246d2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biomet EBI Bone Healing System
• Version Model Number: 1068240
• Catalog Number: 1068240
• 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: true
• Serial Number: false
• 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
• 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 Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• 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 140 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 140 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 140 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 140 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 140 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 140 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 140 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 140 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 140 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 140 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 140 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 140 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 140 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 140 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 140 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 140 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 140 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 140 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 140 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 140 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 140 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 140 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 140 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 140 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 140 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812301020621 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P790002

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 EBI Bone Healing System]

• 00812301020676: BHS DEMO UNIT Biomet EBI Bone Healing System Demonstration Unit Not For Human Use
• 00812301020652: WALL AC ADAPTER
• 00812301020645: STRAP, SFLX CLAVICLE COILETE
• 00812301020638: STRAP, SFLX STANDARD COILETTE
• 00812301020621: SFLX - XL COILETTE
• 00812301020614: SFLX - MINI COILETTE
• 00812301020607: SFLX - COILETTE
• 00812301020591: SFLX 4-4 COIL
• 00812301020584: SFLX 4-1 COIL
• 00812301020577: SFLX 4 COIL
• 00812301020560: BIOMET EBI BONE HEALING SYSTEM
• 00812301020553: CONTROLLER ASSEMBLY, REPLACEMENT - BIOMET EBI BONE HEALING SYSTEM
• 00812301020546: SFLX 3 COIL
• 00812301020539: SFLX 2-4 COIL
• 00812301020522: SFLX 2-1 COIL
• 00812301020515: SFLX 5 COIL
• 00812301020508: SFLX 1 COIL
• 00812301020492: SFLX 5 COIL
• 00812301020485: CABLE 48 REPLACEMENT PART
• 00812301020478: BELT / STRAP REPLACEMENT REPLACEMENT
• 00812301020461: CABLE 28 REPLACEMENT PART
• 00812301020454: CABLE ZERO INCH REPLACEMENT
• 00812301020447: BHS EXTREMITY BAND
• 00812301020430: CLIP HOLDER ASSEMBLY