MINIRAIL SYSTEM 600090

GUDID 18053504366362

Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.

ORTHOFIX SRL

External orthopaedic fixation system, single-use, sterile

• Primary Device ID: 18053504366362
• NIH Device Record Key: 0648bf44-3a21-48c2-94ab-a386342607db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MINIRAIL SYSTEM
• Version Model Number: 1
• Catalog Number: 600090
• 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: 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: +0390456719000
• Email: info@orthofix.it

Device Identifiers

Device Issuing Agency	Device ID
GS1	18053504366362 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955848

FDA Product Code

• JDW: Pin, Fixation, Threaded

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: 2019-04-29
• Device Publish Date: 2019-04-19

On-Brand Devices [MINIRAIL SYSTEM]

• 18032568869996: MINIRAIL, SHORT
• 18032568869965: SPECIAL MINIRAIL SHORT LENGHTNER
• 18032568866872: SCREW FORCEPS
• 18032568866865: T-WRENCH FOR BONE SCREWS
• 18032568866834: MINIRAIL SYSTEM STERI BOX EMPTY
• 18032568866810: CALCANEUM FIXATOR
• 18032568866803: MINIRAIL LENGTHENER & FIXATOR CLAMP COVER
• 18032568866773: PLATE LOCKING SCREW
• 18032568866766: BALL JOINT T-CLAMP (M130)
• 18032568866742: MINIRAIL LENGTHENER & FIXATOR CLAMP COVER SCREW
• 18032568866735: CLAMP COVER (MINI)
• 18032568866711: MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS
• 18032568866681: ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS
• 18032568866667: MINIRAIL, LENGTHENER, T-CLAMP
• 18032568866650: MINIRAIL, SHORT, LENGTHENER
• 18032568866643: MINIRAIL LONG LENGTHENER
• 18032568866636: MINIRAIL, STANDARD, LENGTHENER
• 18032568866551: ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS - DOUBLE SLIDE
• 18032568866544: M2 MULTIPLANAR MINIRAIL
• 18032568866520: DRIVER FOR 3MM SHAFT SCREWS
• 18032568866513: MINI RAIL, NON-SWIVEL, CLAMP COVER
• 18032568865073: MINISANDWICH CLAMP KIT
• 18032568865059: MICROMETRIC ARTICULATED MINIRAIL FIXATOR HORIZ.AXIS
• 18032568865042: ARTICULATED MINIRAIL FIXATOR WITH HINGE
• 18032568865028: MINILENGTHENER TRIPLE CLAMPS
• 18032568864465: BILATERAL MINILENGTHENER L.173 MM
• 18032568864458: BILATERAL MINILENGTHENER L.145 MM
• 18032568864441: BILATERAL MINILENGTHENER L.110 MM
• 18032568864434: BILATERAL MINILENGTHENER L.85 MM
• 18032568039757: CALCANEAL MINIFIXATOR KIT STERILE
• 18032568039696: CALCANEAL TEMPLATE KIT
• 18032568039313: CALCANEAL MINIFIXATOR
• 18032568039221: MINIRAIL TEMPLATE KIT, PKG OF 4
• 18053504366409: Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
• 18053504366393: Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
• 18053504366386: Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
• 18053504366379: Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
• 18053504366362: Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
• 18053504365716: Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
• 18053504365709: Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.