MJ-FLEX 166990C

GUDID 18054242518839

STERILIZATION BOX COMPLETE

ORTHOFIX SRL

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 18054242518839
• NIH Device Record Key: 4748182c-7d97-4f27-85b9-405696e34ac8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MJ-FLEX
• Version Model Number: 1
• Catalog Number: 166990C
• 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: false
• 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: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it

Device Identifiers

Device Issuing Agency	Device ID
GS1	18054242518839 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173051

FDA Product Code

• HTY: Pin, Fixation, Smooth

Sterilization

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

[18054242518839]

Moist Heat or Steam Sterilization

[18054242518839]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-24

On-Brand Devices [MJ-FLEX]

• 18054242518921: MJ-FLEX SS NAIL L450MM D5MM STERILE
• 18054242518914: MJ-FLEX SS NAIL L450MM D4.5MM STERILE
• 18054242518907: MJ-FLEX SS NAIL L450MM D4MM STERILE
• 18054242518891: MJ-FLEX TI NAIL L450MM D5MM STERILE
• 18054242518884: MJ-FLEX TI NAIL L450MM D4.5MM STERILE
• 18054242518877: MJ-FLEX TI NAIL L450MM D4MM STERILE
• 18054242518860: MJ-FLEX TI NAIL L400MM D3.5MM STERILE
• 18054242518853: MJ-FLEX TI NAIL L400MM D3MM STERILE
• 18054242518846: MJ-FLEX TI NAIL L400MM D2.5MM STERILE
• 18054242518839: STERILIZATION BOX COMPLETE
• 18054242518822: STERILIZATION BOX EMPTY
• 18054242518815: HAMMER
• 18054242518808: SLAP HAMMER
• 18054242518792: EXTRACTION PLIERS
• 18054242518785: NAIL IMPACTOR - 4/5
• 18054242518778: NAIL IMPACTOR - 2/3
• 18054242518761: NAIL CUTTER
• 18054242518754: NAIL INSERTER
• 18054242518747: BENDER - LEFT
• 18054242518730: BENDER - RIGHT
• 18054242518723: BONE AWL