Rex Mallet 04000131

GUDID D894040001310

Rex Mallet Console

Rex Implants, Inc.

Orthopaedic implant impactor, reusable

• Primary Device ID: D894040001310
• NIH Device Record Key: c31d31a9-1e37-4e80-a5dd-cec50bf38d9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rex Mallet
• Version Model Number: Rex Mallet
• Catalog Number: 04000131
• Company DUNS: 080746478
• Company Name: Rex Implants, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 6146538429
• Email: info@reximplants.com
• Phone: 6146538429
• Email: info@reximplants.com
• Phone: 6146538429
• Email: info@reximplants.com
• Phone: 6146538429
• Email: info@reximplants.com
• Phone: 6146538429
• Email: info@reximplants.com
• Phone: 6146538429
• Email: info@reximplants.com
• Phone: 6146538429
• Email: info@reximplants.com
• Phone: 6146538429
• Email: info@reximplants.com
• Phone: 6146538429
• Email: info@reximplants.com
• Phone: 6146538429
• Email: info@reximplants.com
• Phone: 6146538429
• Email: info@reximplants.com
• Phone: 6146538429
• Email: info@reximplants.com
• Phone: 6146538429
• Email: info@reximplants.com
• Phone: 6146538429
• Email: info@reximplants.com
• Phone: 6146538429
• Email: info@reximplants.com
• Phone: 6146538429
• Email: info@reximplants.com
• Phone: 6146538429
• Email: info@reximplants.com
• Phone: 6146538429
• Email: info@reximplants.com
• Phone: 6146538429
• Email: info@reximplants.com
• Phone: 6146538429
• Email: info@reximplants.com
• Phone: 6146538429
• Email: info@reximplants.com
• Phone: 6146538429
• Email: info@reximplants.com
• Phone: 6146538429
• Email: info@reximplants.com
• Phone: 6146538429
• Email: info@reximplants.com
• Phone: 6146538429
• Email: info@reximplants.com
• Phone: 6146538429
• Email: info@reximplants.com
• Phone: 6146538429
• Email: info@reximplants.com
• Phone: 6146538429
• Email: info@reximplants.com
• Phone: 6146538429
• Email: info@reximplants.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D894040001310 [Primary]
HIBCC	D894052000021010 [Package]; Package: Conveniece kit [1 Units]; In Commercial Distribution

FDA Product Code

• GEY: Motor, Surgical Instrument, Ac-Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2024-08-05
• Device Publish Date: 2023-01-07

On-Brand Devices [Rex Mallet]

• D894045700121010: Posterior Striker/Remover
• D894045700111010: Crown Remover
• D894045700081010: Anterior Striker
• D894045700071010: Posterior Striker
• D894040001310: Rex Mallet Console
• D894031202471010: Rex Mallet Handpiece
• D894029001541010: Rex Mallet footswitch