coflex Mallet

GUDID 04260148897856

Paradigm Spine, LLC

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 04260148897856
• NIH Device Record Key: 3cd56480-1886-45d9-9137-698572de06df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: coflex Mallet
• Version Model Number: UAT20120
• Company DUNS: 787874960
• Company Name: Paradigm Spine, 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	04260148897856 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P110008

FDA Product Code

• NQO: Prosthesis, Spinous Process Spacer/Plate

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-03
• Device Publish Date: 2018-08-02

On-Brand Devices [coflex Mallet]

• 04260148897856: UAT20120
• 04260148890130: UAT20100