DSS HP Polyaxial pedicle screw set, Ø5 x 45mm

GUDID 00426014889692

Paradigm Spine, LLC

Spinal dynamic-stabilization system

• Primary Device ID: 00426014889692
• NIH Device Record Key: 40ae5779-b59a-45d9-8cfc-29aada43178f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DSS HP Polyaxial pedicle screw set, Ø5 x 45mm
• Version Model Number: HPI85045
• Company DUNS: 787874960
• Company Name: Paradigm Spine, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does n
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00426014889692 [Primary]

FDA Product Code

• NQP: Posterior Metal/Polymer Spinal System, Fusion

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-10-01

On-Brand Devices [DSS HP Polyaxial pedicle screw set, Ø5 x 45mm ]

• 00426014889692: HPI85045
• 04260148896927: HPI85045