Radiolucent Wrist Fixator 36105

GUDID 18032568036060

SELFDRILLING PIN 80/25 MM THREAD DIA. 3.3/3 MM

ORTHOFIX SRL

Orthopaedic bone pin, non-bioabsorbable

• Primary Device ID: 18032568036060
• NIH Device Record Key: 694ab31c-50e1-44ac-b90c-780f717b6e4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Radiolucent Wrist Fixator
• Version Model Number: 1
• Catalog Number: 36105
• 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
• 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 Dimensions

• Device Size Text, specify: 0
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 80 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	18032568036060 [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

[18032568036060]

Moist Heat or Steam Sterilization

[18032568036060]

Moist Heat or Steam Sterilization

[18032568036060]

Moist Heat or Steam Sterilization

[18032568036060]

Moist Heat or Steam Sterilization

[18032568036060]

Moist Heat or Steam Sterilization

[18032568036060]

Moist Heat or Steam Sterilization

[18032568036060]

Moist Heat or Steam Sterilization

[18032568036060]

Moist Heat or Steam Sterilization

[18032568036060]

Moist Heat or Steam Sterilization

[18032568036060]

Moist Heat or Steam Sterilization

[18032568036060]

Moist Heat or Steam Sterilization

[18032568036060]

Moist Heat or Steam Sterilization

[18032568036060]

Moist Heat or Steam Sterilization

[18032568036060]

Moist Heat or Steam Sterilization

[18032568036060]

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

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• 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