PERTROCHANTERIC FIXATOR 11127

GUDID 18032568032376

TROCAR D 4.8 MM LENGTH 240 MM

ORTHOFIX SRL

Orthopaedic trocar blade, reusable

• Primary Device ID: 18032568032376
• NIH Device Record Key: b990883b-83b5-45fd-94f9-5672f00628d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PERTROCHANTERIC FIXATOR
• Version Model Number: 1
• Catalog Number: 11127
• 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 Dimensions

• Outer Diameter: 4.8 Millimeter
• Length: 240 Millimeter
• Outer Diameter: 4.8 Millimeter
• Length: 240 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	18032568032376 [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

[18032568032376]

Moist Heat or Steam Sterilization

[18032568032376]

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: 2018-04-05

On-Brand Devices [PERTROCHANTERIC FIXATOR]

• 18032568032383: TROCAR D 6 MM LENGTH 240 MM
• 18032568032376: TROCAR D 4.8 MM LENGTH 240 MM
• 18032568032369: SPECIAL SCREW GUIDE 150 MM FOR PERTROCHANTERIC FIXATOR
• 18032568030631: ROTATION LOCKING SCREW FOR PERTROCHANTERIC FIXATOR
• 18032568030617: DISTAL ROTATION LOCKING SCREW FOR PERTROCHANTERIC FIXATOR
• 18032568030600: ANGULATION LOCKING SCREW FOR PERTROCHANTERIC FIXATOR
• 18032568030587: PERTROCHANTERIC FIXATOR WITH ALLEN WRENCH 5 MM
• 18053504366263: Component. Not for sale. Used for reporting Direct Marking of assembly.