RADIOLUCENT WRIST FIXATOR 36017

GUDID 18032568036015

ALLEN WRENCH 4 MM

ORTHOFIX SRL

Surgical torque wrench, reusable

• Primary Device ID: 18032568036015
• NIH Device Record Key: ee7ff596-ffbb-4a40-9d93-18078f3a5cbc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RADIOLUCENT WRIST FIXATOR
• Version Model Number: 1
• Catalog Number: 36017
• 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

• Width: 4 Millimeter
• Width: 4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	18032568036015 [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

[18032568036015]

Moist Heat or Steam Sterilization

[18032568036015]

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: 2018-05-01

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