PEMF - CERVICAL-STIM 5505CE

GUDID 18257200105656

5505CE, SHIP ASSY., OSTEOGENESIS STIMULATOR, CERVICAL-STIM, OUS

ORTHOFIX INC.

Flexible video laryngoscope

• Primary Device ID: 18257200105656
• NIH Device Record Key: b78e9373-185d-49a3-9e65-f0c14db984ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PEMF - CERVICAL-STIM
• Version Model Number: 655505-0003
• Catalog Number: 5505CE
• Company DUNS: 927083808
• Company Name: ORTHOFIX INC.
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	18257200105656 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P030034

FDA Product Code

• LOF: Stimulator, bone growth, non-invasive

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[18257200105656]

Moist Heat or Steam Sterilization

[18257200105656]

Moist Heat or Steam Sterilization

[18257200105656]

Moist Heat or Steam Sterilization

[18257200105656]

Moist Heat or Steam Sterilization

[18257200105656]

Moist Heat or Steam Sterilization

[18257200105656]

Moist Heat or Steam Sterilization

[18257200105656]

Moist Heat or Steam Sterilization

[18257200105656]

Moist Heat or Steam Sterilization

[18257200105656]

Moist Heat or Steam Sterilization

[18257200105656]

Moist Heat or Steam Sterilization

[18257200105656]

Moist Heat or Steam Sterilization

[18257200105656]

Moist Heat or Steam Sterilization

[18257200105656]

Moist Heat or Steam Sterilization

[18257200105656]

Moist Heat or Steam Sterilization

[18257200105656]

Moist Heat or Steam Sterilization

[18257200105656]

Moist Heat or Steam Sterilization

[18257200105656]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-07
• Device Publish Date: 2020-01-30

On-Brand Devices [PEMF - CERVICAL-STIM]

• 18257200131440: COMFORT COLLAR, CERVICAL STIM 5505, ACCESSORY
• 18257200123933: 5505CMD, DEMO, SHIP ASSY., OSTEOGENESIS STIMULATOR, CERVICAL-STIM, CM
• 18257200123919: 5505CM, SHIP ASSY., OSTEOGENESIS STIMULATOR, CERVICAL-STIM, CM
• 18257200105663: 5505CED, DEMO, OSTEOGENESIS STIMULATOR, CERVICAL-STIM, OUS
• 18257200105656: 5505CE, SHIP ASSY., OSTEOGENESIS STIMULATOR, CERVICAL-STIM, OUS