Radiolucent Wrist Fixator 99-36501

GUDID 18032568861648

RADIOLUCENT WRIST FIXATOR KIT COMPLETE SYSTEM - STERILE

ORTHOFIX SRL

External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use

• Primary Device ID: 18032568861648
• NIH Device Record Key: 4e8d4872-108d-49e1-867c-517fafe1702a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Radiolucent Wrist Fixator
• Version Model Number: 1
• Catalog Number: 99-36501
• 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: 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
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it

Device Identifiers

Device Issuing Agency	Device ID
GS1	18032568861648 [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 [Radiolucent Wrist Fixator]

• 18032568866384: RADIOLUCENT WRIST FIXATOR KIT STERILE, WITH COATED SCREWS
• 18032568864526: EXTRA SHORT RADIOLUCENT FIXATOR
• 18032568861655: RADIOLUCENT WRIST FIXATOR STERILE
• 18032568861648: RADIOLUCENT WRIST FIXATOR KIT COMPLETE SYSTEM - STERILE
• 18032568861624: RADIOLUCENT WRIST FIXATOR KIT BASIC SYSTEM - STERILE
• 18032568039276: RADIOLUCENT WRIST FIXATOR AND SCREWS - STERILE
• 18032568036060: SELFDRILLING PIN 80/25 MM THREAD DIA. 3.3/3 MM
• 18032568036053: SELFDRILLING PIN 70/20 MM THREAD DIA. 3.3/3 MM
• 18032568036015: ALLEN WRENCH 4 MM