Biomet Bone Healing System 1068317

GUDID 00812301020669

International Wall Plug Adapter Kit

EBI, LLC

Patient-worn bone growth electromagnetic stimulator

• Primary Device ID: 00812301020669
• NIH Device Record Key: 784ab731-b658-49cb-bb4d-2b518f8482e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biomet Bone Healing System
• Version Model Number: 1068317
• Catalog Number: 1068317
• 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: 1.800.526.2579
• Email: btbs.csorders@biomet.com
• Phone: 1.800.526.2579
• Email: btbs.csorders@biomet.com
• Phone: 1.800.526.2579
• Email: btbs.csorders@biomet.com
• Phone: 1.800.526.2579
• Email: btbs.csorders@biomet.com
• Phone: 1.800.526.2579
• Email: btbs.csorders@biomet.com
• Phone: 1.800.526.2579
• Email: btbs.csorders@biomet.com
• Phone: 1.800.526.2579
• Email: btbs.csorders@biomet.com
• Phone: 1.800.526.2579
• Email: btbs.csorders@biomet.com
• Phone: 1.800.526.2579
• Email: btbs.csorders@biomet.com
• Phone: 1.800.526.2579
• Email: btbs.csorders@biomet.com
• Phone: 1.800.526.2579
• Email: btbs.csorders@biomet.com
• Phone: 1.800.526.2579
• Email: btbs.csorders@biomet.com
• Phone: 1.800.526.2579
• Email: btbs.csorders@biomet.com
• Phone: 1.800.526.2579
• Email: btbs.csorders@biomet.com
• Phone: 1.800.526.2579
• Email: btbs.csorders@biomet.com
• Phone: 1.800.526.2579
• Email: btbs.csorders@biomet.com
• Phone: 1.800.526.2579
• Email: btbs.csorders@biomet.com
• Phone: 1.800.526.2579
• Email: btbs.csorders@biomet.com
• Phone: 1.800.526.2579
• Email: btbs.csorders@biomet.com
• Phone: 1.800.526.2579
• Email: btbs.csorders@biomet.com
• Phone: 1.800.526.2579
• Email: btbs.csorders@biomet.com
• Phone: 1.800.526.2579
• Email: btbs.csorders@biomet.com
• Phone: 1.800.526.2579
• Email: btbs.csorders@biomet.com
• Phone: 1.800.526.2579
• Email: btbs.csorders@biomet.com
• Phone: 1.800.526.2579
• Email: btbs.csorders@biomet.com
• Phone: 1.800.526.2579
• Email: btbs.csorders@biomet.com
• Phone: 1.800.526.2579
• Email: btbs.csorders@biomet.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812301020669 [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

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• 00887868269295 - Biomet OrthoPak Non-invasive Bone Growth Stimulator System: 2019-03-11
• 00887868269301 - Biomet OrthoPak Non-invasive Bone Growth Stimulator System: 2019-03-11
• 00887868269318 - Biomet OrthoPak Non-invasive Bone Growth Stimulator System: 2019-03-11
• 00880304820845 - Biomet SpinalPak / OrthoPak: 2018-07-06 BELT EXTENSION, LARGE, SPINALPAK
• 00880304820852 - Biomet SpinalPak / OrthoPak: 2018-07-06 ELECTRODES, 63B, SPINALPAK/ORTHOPAK