GALAXY FIXATION GEMINI 99-94030

GUDID 18053340348720

GALAXY FIXATION GEMINI TRANSITIONAL SINGLE CLAMP STERILE

ORTHOFIX SRL

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