CONTOURS PROXIMAL HUMERAL PLATE (PHP) & LSP TITANIUM HUMERAL PLATE TP3108

GUDID 18054242510574

PLATE HOLDER

ORTHOFIX SRL

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 18054242510574
• NIH Device Record Key: b0bec670-2c0c-48d5-8b8e-e0344ada99e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONTOURS PROXIMAL HUMERAL PLATE (PHP) & LSP TITANIUM HUMERAL PLATE
• Version Model Number: 1
• Catalog Number: TP3108
• 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
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it

Device Dimensions

• Width: 149 Millimeter
• Width: 149 Millimeter
• Width: 149 Millimeter
• Width: 149 Millimeter
• Width: 149 Millimeter
• Width: 149 Millimeter
• Width: 149 Millimeter
• Width: 149 Millimeter
• Width: 149 Millimeter
• Width: 149 Millimeter
• Width: 149 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	18054242510574 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122541

FDA Product Code

• KTW: Appliance, Fixation, Nail/Blade/Plate Combination, Single Component

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[18054242510574]

Moist Heat or Steam Sterilization

[18054242510574]

Moist Heat or Steam Sterilization

[18054242510574]

Moist Heat or Steam Sterilization

[18054242510574]

Moist Heat or Steam Sterilization

[18054242510574]

Moist Heat or Steam Sterilization

[18054242510574]

Moist Heat or Steam Sterilization

[18054242510574]

Moist Heat or Steam Sterilization

[18054242510574]

Moist Heat or Steam Sterilization

[18054242510574]

Moist Heat or Steam Sterilization

[18054242510574]

Moist Heat or Steam Sterilization

[18054242510574]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-23
• Device Publish Date: 2018-05-08

On-Brand Devices [CONTOURS PROXIMAL HUMERAL PLATE (PHP) & LSP TITANIUM HUMERAL PLATE]

• 18054242510611: RULER
• 18054242510574: PLATE HOLDER
• 18054242510550: DRILL GUIDE (D. 3.2MM)
• 18032937169269: MEASURER 2