coflex Crimping pliers

GUDID 04260148898990

Paradigm Spine, LLC

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 04260148898990
• NIH Device Record Key: c9161005-d8e3-415b-979b-1bd0bff391d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: coflex Crimping pliers
• Version Model Number: UAT10220
• 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	04260148898990 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P110008

FDA Product Code

• NQO: Prosthesis, Spinous Process Spacer/Plate

Sterilization

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

[04260148898990]

Moist Heat or Steam Sterilization

[04260148898990]

Moist Heat or Steam Sterilization

[04260148898990]

Moist Heat or Steam Sterilization

[04260148898990]

Moist Heat or Steam Sterilization

[04260148898990]

Moist Heat or Steam Sterilization

[04260148898990]

Moist Heat or Steam Sterilization

[04260148898990]

Moist Heat or Steam Sterilization

[04260148898990]

Moist Heat or Steam Sterilization

[04260148898990]

Moist Heat or Steam Sterilization

[04260148898990]

Moist Heat or Steam Sterilization

[04260148898990]

Moist Heat or Steam Sterilization

[04260148898990]

Moist Heat or Steam Sterilization

[04260148898990]

Moist Heat or Steam Sterilization

[04260148898990]

Moist Heat or Steam Sterilization

[04260148898990]

Moist Heat or Steam Sterilization

[04260148898990]

Moist Heat or Steam Sterilization

[04260148898990]

Moist Heat or Steam Sterilization

[04260148898990]

Moist Heat or Steam Sterilization

[04260148898990]

Moist Heat or Steam Sterilization

[04260148898990]

Moist Heat or Steam Sterilization

[04260148898990]

Moist Heat or Steam Sterilization

[04260148898990]

Moist Heat or Steam Sterilization

[04260148898990]

Moist Heat or Steam Sterilization

[04260148898990]

Moist Heat or Steam Sterilization

[04260148898990]

Moist Heat or Steam Sterilization

[04260148898990]

Moist Heat or Steam Sterilization

[04260148898990]

Moist Heat or Steam Sterilization

[04260148898990]

Moist Heat or Steam Sterilization

[04260148898990]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-06-29

On-Brand Devices [coflex Crimping pliers]

• 04260148898990: UAT10220
• 04260148890123: UAT10200