PAEDIATRIC LIMB RECONSTRUCTION SYSTEM 55031

GUDID 18032568036695

OF-GARCHES T-CLAMP KIT FOR PAEDIATRIC LRS

ORTHOFIX SRL

External orthopaedic fixation system, reusable

• Primary Device ID: 18032568036695
• NIH Device Record Key: 43fab706-f2d2-4b00-babe-e45bef08dd8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PAEDIATRIC LIMB RECONSTRUCTION SYSTEM
• Version Model Number: 1
• Catalog Number: 55031
• 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	18032568036695 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955848

FDA Product Code

• JDW: Pin, Fixation, Threaded

Sterilization

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

[18032568036695]

Moist Heat or Steam Sterilization

[18032568036695]

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: 2018-04-19

On-Brand Devices [PAEDIATRIC LIMB RECONSTRUCTION SYSTEM ]

• 18033509858284: PAEDIATRIC LRS STRAIGTH CLAMP
• 18033509858277: PAEDIATRIC LRS HINGE CONNECTION
• 18032568864632: PAEDIATRIC SANDWICH CLAMP KIT
• 18032568036817: HINGED RAIL COUPLING FOR PAEDIATRIC LRS
• 18032568036800: SWIVELLING CLAMP FOR PAEDIATRIC LRS
• 18032568036794: LOCKING SCREW FOR PAEDIATRIC LRS
• 18032568036787: LONG RAIL LENGTH 25 CM FOR PAEDIATRIC LRS
• 18032568036770: STANDARD RAIL LENGTH 20 CM FOR PAEDIATRIC LRS
• 18032568036763: SHORT RAIL LENGTH 15 CM FOR PAEDIATRIC LRS
• 18032568036756: EXTRA-SHORT RAIL LENGTH 10 CM FOR PAEDIATRIC LRS
• 18032568036749: STRAIGHT CLAMP FOR PAEDIATRIC LRS
• 18032568036732: BALL-JOINT COUPLING FOR PAEDIATRIC LRS
• 18032568036725: DYNA-RING WITH C/D UNIT ATTACH FOR PAEDIATRIC LRS
• 18032568036695: OF-GARCHES T-CLAMP KIT FOR PAEDIATRIC LRS
• 18032568036688: PAEDIATRIC LRS T-CLAMP
• 18032568036671: PAEDIATRIC LRS LONG KIT
• 18032568036664: PAEDIATRIC LRS STANDARD KIT
• 18032568036657: PAEDIATRIC LRS C/D UNIT EXTENDS TO 6.2 CM
• 18032568036640: PAEDIATRIC LRS SHORT KIT
• 18032568033502: TEMPLATE LOCKING SCREW PAEDIATRIC LRS
• 18032568033496: BALL-JOINT COUPLING TEMPLATE PAEDIATRIC LRS
• 18032568033489: SWIVELLING CLAMP TEMPLATE PAEDIATRIC LRS
• 18032568033472: T-CLAMP TEMPLATE PAEDIATRIC LRS
• 18032568033465: STRAIGHT CLAMP TEMPLATE PAEDIATRIC LRS
• 18032568032819: PAEDIATRIC LRS STERI BOX EMPTY
• 18053504369998: Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
• 18053504369813: Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
• 18053504369806: Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
• 18053504369714: Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
• 18053504369707: Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
• 18053504369684: Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
• 18053504369677: Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
• 18053504369660: Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
• 18053504369653: Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
• 18053504366355: Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
• 18053504366348: Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
• 18053504366331: Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
• 18053504366324: Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
• 18053504366300: Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
• 18053504365372: Component. Not for sale. Used for reporting Direct Marking of assembly.
• 18053504364726: Component. Not for sale. Used for reporting Direct Marking of assembly.