Orthofix Osteogenesis Stimulator 653315-0017

GUDID 18257200080779

Physio-Stim Osteogenesis Stimulator

ORTHOFIX INC.

Patient-worn bone growth electromagnetic stimulator

• Primary Device ID: 18257200080779
• NIH Device Record Key: 5decabd6-0364-4c01-a619-287721c5d7b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orthofix Osteogenesis Stimulator
• Version Model Number: 3315
• Catalog Number: 653315-0017
• 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: false
• 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 Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	18257200080779 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P850007

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: 2015-05-12

On-Brand Devices [Orthofix Osteogenesis Stimulator]

• 18257200080823: Cervical-Stim Osteogenesis Stimulator, Demo
• 18257200080816: Cervical-Stim Osteogenesis Stimulator
• 18257200080809: Spinal-Stim Osteogensis Stimulator, Demo
• 18257200080793: Spinal-Stim Osteogenesis Stimulator
• 18257200080786: Physio-Stim Osteogenesis Stimulator, Demo
• 18257200080779: Physio-Stim Osteogenesis Stimulator
• 18257200080762: Physio-Stim Osteogensis Stimulator, Demo
• 18257200080755: Physio-Stim Osteogenesis Stimulator
• 18257200080748: Physio-Stim Osteogenesis Stimulator, Demo
• 18257200080731: Physio-Stim Osteogenesis Stimulator
• 18257200080724: Physio-Stim Osteogensis Stimulator, Demo
• 18257200080717: Physio-Stim Osteogenesis Stimulator
• 18257200080700: Physio-Stim Osteogenesis Stimulator, Demo
• 18257200080694: Physio-Stim Osteogenesis Stimulator
• 18257200080687: Physio-Stim Osteogenesis Stimulator, Demo
• 18257200080670: Physio-Stim Osteogenesis Stimulator