coflex crimping pliers, long

GUDID 04260148897825

Paradigm Spine, LLC

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 04260148897825
• NIH Device Record Key: db078d10-2f1c-453a-a30f-032701c61d00
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: coflex crimping pliers, long
• Version Model Number: UAT10250
• 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	04260148897825 [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

[04260148897825]

Moist Heat or Steam Sterilization

[04260148897825]

Moist Heat or Steam Sterilization

[04260148897825]

Moist Heat or Steam Sterilization

[04260148897825]

Moist Heat or Steam Sterilization

[04260148897825]

Moist Heat or Steam Sterilization

[04260148897825]

Moist Heat or Steam Sterilization

[04260148897825]

Moist Heat or Steam Sterilization

[04260148897825]

Moist Heat or Steam Sterilization

[04260148897825]

Moist Heat or Steam Sterilization

[04260148897825]

Moist Heat or Steam Sterilization

[04260148897825]

Moist Heat or Steam Sterilization

[04260148897825]

Moist Heat or Steam Sterilization

[04260148897825]

Moist Heat or Steam Sterilization

[04260148897825]

Moist Heat or Steam Sterilization

[04260148897825]

Moist Heat or Steam Sterilization

[04260148897825]

Moist Heat or Steam Sterilization

[04260148897825]

Moist Heat or Steam Sterilization

[04260148897825]

Moist Heat or Steam Sterilization

[04260148897825]

Moist Heat or Steam Sterilization

[04260148897825]

Moist Heat or Steam Sterilization

[04260148897825]

Moist Heat or Steam Sterilization

[04260148897825]

Moist Heat or Steam Sterilization

[04260148897825]

Moist Heat or Steam Sterilization

[04260148897825]

Moist Heat or Steam Sterilization

[04260148897825]

Moist Heat or Steam Sterilization

[04260148897825]

Moist Heat or Steam Sterilization

[04260148897825]

Moist Heat or Steam Sterilization

[04260148897825]

Moist Heat or Steam Sterilization

[04260148897825]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-23
• Device Publish Date: 2018-10-23

Devices Manufactured by Paradigm Spine, LLC

• 04260148898235 - CoFix Implant 8 mm: 2020-03-27
• 04260148898242 - CoFix Implant 10 mm: 2020-03-27
• 04260148898259 - CoFix Implant 12 mm: 2020-03-27
• 04260148898266 - CoFix Implant 14 mm: 2020-03-27
• 04260148898273 - CoFix Implant 16 mm: 2020-03-27
• 04260148897931 - CoFix Sterilization Tray: 2020-03-12
• 04260636670459 - coflex-F LIS screw inserter: 2020-03-12
• 04260148896927 - DSS HP Polyaxial pedicle screw set, Ø5 x 45mm: 2019-09-26