NAVIGATED INSTRUMENTS;PHOENIX SFS

GUDID 18257200119448

6.5MM, CANNULATED TAP, PHOENIX NAVIGATED MDT

ORTHOFIX INC.

Growth-correction orthopaedic fixation plate kit

• Primary Device ID: 18257200119448
• NIH Device Record Key: 4f8cbb37-5e4b-489d-897e-f43b63f8cceb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NAVIGATED INSTRUMENTS;PHOENIX SFS
• Version Model Number: 20-1216
• 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: true
• 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	18257200119448 [Primary]

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

[18257200119448]

Moist Heat or Steam Sterilization

[18257200119448]

Moist Heat or Steam Sterilization

[18257200119448]

Moist Heat or Steam Sterilization

[18257200119448]

Moist Heat or Steam Sterilization

[18257200119448]

Moist Heat or Steam Sterilization

[18257200119448]

Moist Heat or Steam Sterilization

[18257200119448]

Moist Heat or Steam Sterilization

[18257200119448]

Moist Heat or Steam Sterilization

[18257200119448]

Moist Heat or Steam Sterilization

[18257200119448]

Moist Heat or Steam Sterilization

[18257200119448]

Moist Heat or Steam Sterilization

[18257200119448]

Moist Heat or Steam Sterilization

[18257200119448]

Moist Heat or Steam Sterilization

[18257200119448]

Moist Heat or Steam Sterilization

[18257200119448]

Moist Heat or Steam Sterilization

[18257200119448]

Moist Heat or Steam Sterilization

[18257200119448]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-11
• Device Publish Date: 2020-02-03

On-Brand Devices [NAVIGATED INSTRUMENTS;PHOENIX SFS]

• 18257200121953: 8.5MM DILATOR SLEEVE, PHOENIX NAVIGATED
• 18257200121854: DILATOR SLEEVE, PHOENIX NAVIGATED
• 18257200121793: 8.5MM DAT SLEEVE, PHOENIX NAVIGATED
• 18257200121786: DAT SLEEVE, PHOENIX NAVIGATED
• 18257200119714: MULTIAXIAL SCREW DRIVER, PHOENIX NAVIGATED BL
• 18257200119707: CANNULATED TAP, 8.5MM, PHOENIX NAVIGATED BL
• 18257200119691: CANNULATED TAP, 7.5MM, PHOENIX NAVIGATED BL
• 18257200119684: CANNULATED TAP, 6.5MM, PHOENIX NAVIGATED BL
• 18257200119677: CANNULATED TAP, 5.5MM, PHOENIX NAVIGATED BL
• 18257200119660: CANNULATED TAP, 4.5MM, PHOENIX NAVIGATED BL
• 18257200119479: MULTIAXIAL SCREW DRIVER, PHOENIX NAVIGATED MDT
• 18257200119462: 8.5MM, CANNULATED TAP, PHOENIX NAVIGATED MDT
• 18257200119455: 7.5MM, CANNULATED TAP, PHOENIX NAVIGATED MDT
• 18257200119448: 6.5MM, CANNULATED TAP, PHOENIX NAVIGATED MDT
• 18257200119431: 5.5MM, CANNULATED TAP, PHOENIX NAVIGATED MDT
• 18257200119424: 4.5MM, CANNULATED TAP, PHOENIX NAVIGATED MDT