Physio-Stim

GUDID 18257200079117

Strap, Model 3315 Replacement

ORTHOFIX INC.

Patient-worn bone growth electromagnetic stimulator

• Primary Device ID: 18257200079117
• NIH Device Record Key: 503ab2a6-ea59-45bc-9169-acc4dc17bca0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Physio-Stim
• Version Model Number: 400378-0001
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	18257200079117 [Primary]

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2014-09-24

On-Brand Devices [Physio-Stim]

• 18257200079315: Physio-Stim Bone Growth Stimulator
• 18257200079308: Physio-Stim Bone Growth Stimulator
• 18257200079285: Physio-Stim Bone Growth Stimulator
• 18257200079278: Physio-Stim Bone Growth Stimulator
• 18257200079254: Physio-Stim Bone Growth Stimulator
• 18257200079247: Physio-Stim Bone Growth Stimulator
• 18257200079223: Physio-Stim Bone Growth Stimulator
• 18257200079216: Physio-Stim Bone Growth Stimulator
• 18257200079193: Physio-Stim Bone Growth Stimulator
• 18257200079186: Physio-Stim Bone Growth Stimulator
• 18257200079162: Physio-Stim Bone Growth Stimulator
• 18257200079155: Physio-Stim Bone Growth Stimulator
• 18257200079117: Strap, Model 3315 Replacement
• 18257200079100: Strap, 3313/3314 Replacement
• 18257200079056: Physio-Stim Bone Growth Stimulator
• 18257200079049: Physio-Stim Bone Growth Stimulator
• 18257200079032: Physio-Stim Bone Growth Stimulator
• 18257200079025: Physio-Stim Bone Growth Stimulator
• 18257200079018: Physio-Stim Bone Growth Stimulator
• 18257200079001: Physio-Stim Bone Growth Stimulator
• 18257200078998: Physio-Stim Bone Growth Stimulator
• 18257200078981: Physio-Stim Bone Growth Stimulator
• 18257200078974: Physio-Stim Bone Growth Stimulator
• 18257200078967: Physio-Stim Bone Growth Stimulator
• 18257200078950: Physio-Stim Bone Growth Stimulator
• 18257200078943: Physio-Stim Bone Growth Stimulator