GALAXY FIXATION GEMINI 99-94030

GUDID 18053340348720

GALAXY FIXATION GEMINI TRANSITIONAL SINGLE CLAMP STERILE

ORTHOFIX SRL

External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable

• Primary Device ID: 18053340348720
• NIH Device Record Key: 8bbc0028-5c5e-4fe4-b510-22845fe20cc3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GALAXY FIXATION GEMINI
• Version Model Number: 1
• Catalog Number: 99-94030
• Company DUNS: 438793622
• Company Name: ORTHOFIX SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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: +390456719000
• Email: info@orthofix.it
• Phone: +390456719000
• Email: info@orthofix.it
• Phone: +390456719000
• Email: info@orthofix.it
• Phone: +390456719000
• Email: info@orthofix.it
• Phone: +390456719000
• Email: info@orthofix.it
• Phone: +390456719000
• Email: info@orthofix.it
• Phone: +390456719000
• Email: info@orthofix.it
• Phone: +390456719000
• Email: info@orthofix.it
• Phone: +390456719000
• Email: info@orthofix.it
• Phone: +390456719000
• Email: info@orthofix.it
• Phone: +390456719000
• Email: info@orthofix.it
• Phone: +390456719000
• Email: info@orthofix.it
• Phone: +390456719000
• Email: info@orthofix.it
• Phone: +390456719000
• Email: info@orthofix.it
• Phone: +390456719000
• Email: info@orthofix.it
• Phone: +390456719000
• Email: info@orthofix.it
• Phone: +390456719000
• Email: info@orthofix.it

Device Identifiers

Device Issuing Agency	Device ID
GS1	18053340348720 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113770

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-04
• Device Publish Date: 2021-12-27

On-Brand Devices [GALAXY FIXATION GEMINI]

• 18053340348898: GALAXY FIXATION GEMINI STERILIZATION TRAY LAYER
• 18053340348881: GALAXY FIXATION GEMINI STERILIZATION TRAY BASE
• 18053340348874: GALAXY FIXATION GEMINI STERILIZATION TRAY LID
• 18053340348867: GALAXY FIXATION GEMINI STERILIZATION TRAY EMPTY
• 18053340348850: GALAXY FIXATION GEMINI QUADRILATERAL SET COMPLETE STERILE
• 18053340348843: GALAXY FIXATION GEMINI METATARSAL SET COMPLETE STERILE
• 18053340348836: GALAXY FIXATION GEMINI ANKLE 4MM SET COMPLETE STERILE
• 18053340348829: GALAXY FIXATION GEMINI ANKLE 6MM SET COMPLETE STERILE
• 18053340348812: GALAXY FIXATION GEMINI Z FRAME SET COMPLETE STERILE
• 18053340348805: GALAXY FIXATION GEMINI PELVIS SET COMPLETE STERILE
• 18053340348775: GALAXY FIXATION GEMINI MULTIPIN CLAMP STERILE
• 18053340348768: GALAXY FIXATION GEMINI UNIVERSAL MULTIPIN CLAMP
• 18053340348751: GALAXY FIXATION GEMINI DOUBLE MULTIPIN CLAMP MEDIUM STERILE
• 18053340348744: GALAXY FIXATION GEMINI DOUBLE MULTIPIN CLAMP STERILE
• 18053340348737: GALAXY FIXATION GEMINI DOUBLE UNIVERSAL MULTIPIN CLAMP
• 18053340348720: GALAXY FIXATION GEMINI TRANSITIONAL SINGLE CLAMP STERILE
• 18053340348713: GALAXY FIXATION GEMINI SINGLE CLAMP STERILE
• 18053340348706: GALAXY FIXATION GEMINI UNIVERSAL SINGLE CLAMP
• 18052469472583: GALAXY FIXATION GEMINI SCREW GUIDE
• 18052469472576: GALAXY FIXATION GEMINI TROCAR