coflex instrument loaner set UQS00100

GUDID 04260636678998

instrument loaner set

Paradigm Spine GmbH

General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit

• Primary Device ID: 04260636678998
• NIH Device Record Key: 63af6fc8-5106-449b-9b47-20801e342b6a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: coflex instrument loaner set
• Version Model Number: UQS00100
• Catalog Number: UQS00100
• Company DUNS: 537619731
• Company Name: Paradigm Spine GmbH
• 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: true
• 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	04260636678998 [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

[04260636678998]

Moist Heat or Steam Sterilization

[04260636678998]

Moist Heat or Steam Sterilization

[04260636678998]

Moist Heat or Steam Sterilization

[04260636678998]

Moist Heat or Steam Sterilization

[04260636678998]

Moist Heat or Steam Sterilization

[04260636678998]

Moist Heat or Steam Sterilization

[04260636678998]

Moist Heat or Steam Sterilization

[04260636678998]

Moist Heat or Steam Sterilization

[04260636678998]

Moist Heat or Steam Sterilization

[04260636678998]

Moist Heat or Steam Sterilization

[04260636678998]

Moist Heat or Steam Sterilization

[04260636678998]

Moist Heat or Steam Sterilization

[04260636678998]

Moist Heat or Steam Sterilization

[04260636678998]

Moist Heat or Steam Sterilization

[04260636678998]

Moist Heat or Steam Sterilization

[04260636678998]

Moist Heat or Steam Sterilization

[04260636678998]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-10
• Device Publish Date: 2023-03-31

Devices Manufactured by Paradigm Spine GmbH

• 04260636678998 - coflex instrument loaner set: 2023-04-10instrument loaner set
• 04260636678998 - coflex instrument loaner set: 2023-04-10 instrument loaner set
• 04260636678912 - CoFix instrument loaner set: 2021-06-29
• 04260636678929 - CoFix implant loaner set: 2021-06-29
• 04260636673467 - SImmetry, Blunt Pin, 3.2mm: 2021-02-02
• 04260636673474 - SImmetry, Impactor: 2021-02-02
• 04260636673481 - SImmetry, Long Pin, 3.2mm: 2021-02-02
• 04260636673498 - SImmetry, Short Pin, 3.2mm: 2021-02-02
• 04260636673504 - SImmetry, Working Cannula: 2021-02-02