Cervical-STIM 65505-0001

GUDID 18257200105632

Osteogenesis Cervical-STIM US

ORTHOFIX INC.

Patient-worn bone growth electromagnetic stimulator

• Primary Device ID: 18257200105632
• NIH Device Record Key: 83a2aa93-deb8-45ce-9542-bf7d1d4a962f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cervical-STIM
• Version Model Number: 5505
• Catalog Number: 65505-0001
• Company DUNS: 927083808
• Company Name: ORTHOFIX INC.
• Device Count: 1
• DM Exempt: true
• 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(214)937-2718
• Email: pemfcustomerservice@orthofix.c
• Phone: +1(214)937-2718
• Email: pemfcustomerservice@orthofix.c
• Phone: +1(214)937-2718
• Email: pemfcustomerservice@orthofix.com
• Phone: +1(214)937-2718
• Email: pemfcustomerservice@orthofix.com
• Phone: +1(214)937-2718
• Email: pemfcustomerservice@orthofix.com
• Phone: +1(214)937-2718
• Email: pemfcustomerservice@orthofix.com
• Phone: +1(214)937-2718
• Email: pemfcustomerservice@orthofix.com
• Phone: +1(214)937-2718
• Email: pemfcustomerservice@orthofix.com
• Phone: +1(214)937-2718
• Email: pemfcustomerservice@orthofix.com
• Phone: +1(214)937-2718
• Email: pemfcustomerservice@orthofix.com
• Phone: +1(214)937-2718
• Email: pemfcustomerservice@orthofix.com
• Phone: +1(214)937-2718
• Email: pemfcustomerservice@orthofix.com
• Phone: +1(214)937-2718
• Email: pemfcustomerservice@orthofix.com
• Phone: +1(214)937-2718
• Email: pemfcustomerservice@orthofix.com
• Phone: +1(214)937-2718
• Email: pemfcustomerservice@orthofix.com
• Phone: +1(214)937-2718
• Email: pemfcustomerservice@orthofix.com
• Phone: +1(214)937-2718
• Email: pemfcustomerservice@orthofix.com
• Phone: +1(214)937-2718
• Email: pemfcustomerservice@orthofix.com

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	18257200105632 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P030034

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: 2017-01-23

On-Brand Devices [Cervical-STIM]

• 18257200105649: Osteogenesis Stimulator Cervical-STIM US DEMO
• 18257200105632: Osteogenesis Cervical-STIM US
• 18257200079131: Cervical-Stim Bone Growth Stimulator
• 18257200079094: Comfort Collar
• 18257200078936: Cervical-Stim Bone Growth Stimulator
• 18257200007165: Cervical-Stim Bone Growth Stimulator
• 18257200007158: Cervical-Stim Bone Growth Stimulator