Galaxy Unyco 99-93793

GUDID 18054242513650

GALAXY UNYCO ANKLE - BRIDGING BOX - DELTA FRAME

ORTHOFIX SRL

External orthopaedic fixation system, single-use, sterile

• Primary Device ID: 18054242513650
• NIH Device Record Key: f9ef3ba2-91d2-4772-9b10-77f80d186a50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Galaxy Unyco
• Version Model Number: 1
• Catalog Number: 99-93793
• Company DUNS: 438793622
• Company Name: ORTHOFIX SRL
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• 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: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it

Device Identifiers

Device Issuing Agency	Device ID
GS1	18054242513650 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153233

FDA Product Code

• KTT: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-03-02

On-Brand Devices [Galaxy Unyco]

• 18054242515180: GALAXY UNYCO KIT LONG CANCELLOUS SCREWS STERILE (PACK OF 2)
• 18054242515173: GALAXY UNYCO MINI KIT FEMUR STERILE
• 18054242515166: GALAXY UNYCO KNEE BRIDGING BOX
• 18054242515159: GALAXY UNYCO DIAPHYSEAL FEMUR BOX
• 18054242513667: GALAXY UNYCO DIAPHYSEAL TIBIA BOX
• 18054242513650: GALAXY UNYCO ANKLE - BRIDGING BOX - DELTA FRAME
• 18054242513643: GALAXY UNYCO ANKLE BRIDGING BOX - UNILATERAL FRAME
• 18054242513636: GALAXY UNYCO CANCELLOUS SCREW KIT STERILE
• 18054242513629: GALAXY UNYCO MINI KIT INSTRUMENTS STERILE
• 18054242513612: GALAXY UNYCO MINI KIT ANKLE UNILATERAL STERILE
• 18054242513605: GALAXY UNYCO MINI KIT TIBIA STERILE
• 18054242512325: GALAXY UNYCO DIAPHYSEAL TIBIA STERILE KIT
• 18054242512318: POWER DRILL TORQUE LIMITER
• 18054242512301: LIMITED TORQUE WRENCH
• 18054242512295: THREADED WIRE (PACK OF 2)