Vilex Tool XFX-300

GUDID 00841132180631

Wire Cutter & Bending Pliers

ORTHOPEDIATRICS CORP.

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• Primary Device ID: 00841132180631
• NIH Device Record Key: 0b08d805-216b-46aa-a1b1-256c9792a259
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vilex Tool
• Version Model Number: XFX-300
• Catalog Number: XFX-300
• Company DUNS: 796416191
• Company Name: ORTHOPEDIATRICS CORP.
• 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: false
• Serial Number: true
• Manufacturing Date: false
• 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: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841132180631 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052196

FDA Product Code

• FSM: TRAY, SURGICAL, INSTRUMENT

Sterilization

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

[00841132180631]

Moist Heat or Steam Sterilization

[00841132180631]

Moist Heat or Steam Sterilization

[00841132180631]

Moist Heat or Steam Sterilization

[00841132180631]

Moist Heat or Steam Sterilization

[00841132180631]

Moist Heat or Steam Sterilization

[00841132180631]

Moist Heat or Steam Sterilization

[00841132180631]

Moist Heat or Steam Sterilization

[00841132180631]

Moist Heat or Steam Sterilization

[00841132180631]

Moist Heat or Steam Sterilization

[00841132180631]

Moist Heat or Steam Sterilization

[00841132180631]

Moist Heat or Steam Sterilization

[00841132180631]

Moist Heat or Steam Sterilization

[00841132180631]

Moist Heat or Steam Sterilization

[00841132180631]

Moist Heat or Steam Sterilization

[00841132180631]

Moist Heat or Steam Sterilization

[00841132180631]

Moist Heat or Steam Sterilization

[00841132180631]

Moist Heat or Steam Sterilization

[00841132180631]

Moist Heat or Steam Sterilization

[00841132180631]

Moist Heat or Steam Sterilization

[00841132180631]

Moist Heat or Steam Sterilization

[00841132180631]

Moist Heat or Steam Sterilization

[00841132180631]

Moist Heat or Steam Sterilization

[00841132180631]

Moist Heat or Steam Sterilization

[00841132180631]

Moist Heat or Steam Sterilization

[00841132180631]

Moist Heat or Steam Sterilization

[00841132180631]

Moist Heat or Steam Sterilization

[00841132180631]

Moist Heat or Steam Sterilization

[00841132180631]

Moist Heat or Steam Sterilization

[00841132180631]

Moist Heat or Steam Sterilization

[00841132180631]

Moist Heat or Steam Sterilization

[00841132180631]

Moist Heat or Steam Sterilization

[00841132180631]

Moist Heat or Steam Sterilization

[00841132180631]

Moist Heat or Steam Sterilization

[00841132180631]

Moist Heat or Steam Sterilization

[00841132180631]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-09
• Device Publish Date: 2020-02-28

On-Brand Devices [Vilex Tool]

• 00841132180662: Pin Cutter, Double Action
• 00841132180655: Wire Cutter & Bending Pliers
• 00841132180631: Wire Cutter & Bending Pliers
• 00841132180624: Rail Tray
• 00841132180617: Strut & Hardware Tray
• 00841132180600: Ring Tray
• 00841132178751: Tray, Orthex Drill
• 00841132177921: Orthex Small Bone Ring Tray
• 00841132177914: Orthex Small Bone Drill Tray
• 00841132177907: Orthex Small Bone Cubes & Struts Tray
• 00841132177891: Orthex Small Bone Hardware Tray
• 00841132181003: Orthex, Hex Driver, 3mm
• 00841132180990: Orthex, Hex Driver, 2mm
• 00841132180709: Tensioner, Short Nose
• 00841132179932: Orthex Sleeve wire SB 3.5x75mm
• 00841132179925: Orthex Sleeve wire SB 3.5x155mm
• 00841132179918: Orthex Sleeve wire SB 2.7x75mm
• 00841132179901: Orthex Sleeve wire SB 2.7x155mm
• 00841132179895: Orthex Sleeve wire SB 2.0x75mm
• 00841132179857: 4.5 drill sleeve, Short
• 00841132179840: 4.5 drill sleeve, Long
• 00841132179833: Wire Sleeve 6.0x4.5x100mm
• 00841132179826: 3.2 drill sleeve, Short
• 00841132179819: 3.2 drill sleeve, Long
• 00841132179802: 2.0 drill sleeve, Short
• 00841132179796: 2.0 drill sleeve, Long