Procallus Fixator 99-90046

GUDID 18032568863246

RADIOLUCENT ANKLE CLAMP STERILE

ORTHOFIX SRL

External orthopaedic fixation system, reusable

• Primary Device ID: 18032568863246
• NIH Device Record Key: 7a416ca5-20d4-4f9c-bf78-bfe88342e22a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Procallus Fixator
• Version Model Number: 1
• Catalog Number: 99-90046
• 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: true
• 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: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it

Device Identifiers

Device Issuing Agency	Device ID
GS1	18032568863246 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-01

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