EBI OsteoGen™ Implantable Bone Growth Stimulator 10-1320M

GUDID 00812301020034

OSTEOGEN-20/M

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: 00812301020034
• NIH Device Record Key: 7e7ca842-0716-4612-814f-64598581e34f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EBI OsteoGen™ Implantable Bone Growth Stimulator
• Version Model Number: 10-1320M
• Catalog Number: 10-1320M
• 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: true
• Manufacturing Date: true
• 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: 1.973.299.9300
• 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 41 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 0 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812301020034 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P790005

FDA Product Code

• LOE: Stimulator, Invasive Bone Growth

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: 2014-09-19

On-Brand Devices [EBI OsteoGen™ Implantable Bone Growth Stimulator]

• 00812301020119: OSTEOGEN-40/S
• 00812301020102: OSTEOGEN-40/M
• 00812301020072: OSTEOGEN-20/SL
• 00812301020065: OSTEOGEN-20/ML
• 00812301020058: OSTEOGEN-40/SL
• 00812301020041: OSTEOGEN-40/ML
• 00812301020034: OSTEOGEN-20/M
• 00812301020027: OSTEOGEN-20/S