REDEMPTION DUO Nail System RD-TARG-PXE

GUDID 00841731135537

REDEMPTION DUO Proximal Guide Extender

VILEX LLC

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 00841731135537
• NIH Device Record Key: 4a032987-9ca1-4383-9b48-dea2724bcf8f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REDEMPTION DUO Nail System
• Version Model Number: RD-TARG-PXE
• Catalog Number: RD-TARG-PXE
• Company DUNS: 117502293
• Company Name: VILEX LLC
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841731135537 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231343

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories

Sterilization

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

[00841731135537]

Moist Heat or Steam Sterilization

[00841731135537]

Moist Heat or Steam Sterilization

[00841731135537]

Moist Heat or Steam Sterilization

[00841731135537]

Moist Heat or Steam Sterilization

[00841731135537]

Moist Heat or Steam Sterilization

[00841731135537]

Moist Heat or Steam Sterilization

[00841731135537]

Moist Heat or Steam Sterilization

[00841731135537]

Moist Heat or Steam Sterilization

[00841731135537]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-20
• Device Publish Date: 2024-11-12

On-Brand Devices [REDEMPTION DUO Nail System]

• 00841731142528: REDEMPTION DUO Insertion Tool
• 00841731135537: REDEMPTION DUO Proximal Guide Extender
• 00841731135186: REDEMPTION DUO Heel Cup Assembly
• 00841731135162: REDEMPTION DUO Nail Attachment Rod
• 00841731135155: REDEMPTION DUO Distal Arm Assembly
• 00841731135148: REDEMPTION DUO Proximal Arm Assembly