Procallus Fixator 11014

GUDID 18032568032086

X-WIRE WITHOUT OLIVE DIAMETER 1.5 MM LENGTH 250 MM

ORTHOFIX SRL

Orthopaedic bone wire

• Primary Device ID: 18032568032086
• NIH Device Record Key: aa324c38-3079-4850-8a39-983a19dd6e6a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Procallus Fixator
• Version Model Number: 1
• Catalog Number: 11014
• 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: true
• 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: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it

Device Dimensions

• Length: 250 Millimeter
• Outer Diameter: 1.5 Millimeter
• Length: 250 Millimeter
• Outer Diameter: 1.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	18032568032086 [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

[18032568032086]

Moist Heat or Steam Sterilization

[18032568032086]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

On-Brand Devices [Procallus Fixator]

• 18032568863277: RADIOLUCENT ANKLE CLAMP KIT STERILE
• 18032568863246: RADIOLUCENT ANKLE CLAMP STERILE
• 18032568032086: X-WIRE WITHOUT OLIVE DIAMETER 1.5 MM LENGTH 250 MM