LIGHTFIXVISTA 332200

GUDID 18053340348935

LIGHTFIXVISTA BAR L200MM D12MM

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

• Primary Device ID: 18053340348935
• NIH Device Record Key: 42e73a05-3c43-4c53-98e4-536aa9bd2d53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LIGHTFIXVISTA
• Version Model Number: 1
• Catalog Number: 332200
• 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: false
• 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: 0456719000
• Email: info@orthofix.it
• Phone: 0456719000
• Email: info@orthofix.it
• Phone: 0456719000
• Email: info@orthofix.it
• Phone: 0456719000
• Email: info@orthofix.it
• Phone: 0456719000
• Email: info@orthofix.it
• Phone: 0456719000
• Email: info@orthofix.it
• Phone: 0456719000
• Email: info@orthofix.it

Device Dimensions

• Length: 250 Millimeter
• Length: 250 Millimeter
• Length: 250 Millimeter
• Length: 250 Millimeter
• Length: 250 Millimeter
• Length: 250 Millimeter
• Length: 250 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	18053340348935 [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: true
• Device Is Sterile: false

[18053340348935]

Moist Heat or Steam Sterilization

[18053340348935]

Moist Heat or Steam Sterilization

[18053340348935]

Moist Heat or Steam Sterilization

[18053340348935]

Moist Heat or Steam Sterilization

[18053340348935]

Moist Heat or Steam Sterilization

[18053340348935]

Moist Heat or Steam Sterilization

[18053340348935]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-13
• Device Publish Date: 2022-06-03

On-Brand Devices [LIGHTFIXVISTA ]

• 18053800895900: LIGHTFIXVISTA STERILIZATION TRAY LAYER
• 18053340349055: LIGHTFIXVISTA STERILIZATION TRAY LID
• 18053340349048: LIGHTFIXVISTA STERILIZATION TRAY BASE
• 18053340349031: LIGHTFIXVISTA STERILIZATION TRAY EMPTY
• 18053340348973: LIGHTFIXVISTA BAR L400MM D12MM
• 18053340348966: LIGHTFIXVISTA BAR L350MM D12MM
• 18053340348959: LIGHTFIXVISTA BAR L300MM D12MM
• 18053340348942: LIGHTFIXVISTA BAR L250MM D12MM
• 18053340348935: LIGHTFIXVISTA BAR L200MM D12MM
• 18053340348928: LIGHTFIXVISTA BAR L150MM D12MM
• 18053340348911: LIGHTFIXVISTA MULTIPIN CLAMP
• 18053340348904: LIGHTFIXVISTA SINGLE CLAMP