Distractor

GUDID 07290115935561

PREMIA SPINE LTD

Orthopaedic surgical distractor, internal

• Primary Device ID: 07290115935561
• NIH Device Record Key: b8c6b62f-7f5b-49ed-8689-3b6774fab3f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Distractor
• Version Model Number: 86601
• Company DUNS: 649220779
• Company Name: PREMIA SPINE LTD
• 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	07290115935561 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150380

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[07290115935561]

Moist Heat or Steam Sterilization

[07290115935561]

Moist Heat or Steam Sterilization

[07290115935561]

Moist Heat or Steam Sterilization

[07290115935561]

Moist Heat or Steam Sterilization

[07290115935561]

Moist Heat or Steam Sterilization

[07290115935561]

Moist Heat or Steam Sterilization

[07290115935561]

Moist Heat or Steam Sterilization

[07290115935561]

Moist Heat or Steam Sterilization

[07290115935561]

Moist Heat or Steam Sterilization

[07290115935561]

Moist Heat or Steam Sterilization

[07290115935561]

Moist Heat or Steam Sterilization

[07290115935561]

Moist Heat or Steam Sterilization

[07290115935561]

Moist Heat or Steam Sterilization

[07290115935561]

Moist Heat or Steam Sterilization

[07290115935561]

Moist Heat or Steam Sterilization

[07290115935561]

Moist Heat or Steam Sterilization

[07290115935561]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-18
• Device Publish Date: 2024-10-10

On-Brand Devices [Distractor]

• 07290115934342: 86299
• 07290115935561: 86601