MIS Cannulated Pedicle Probe

GUDID 07290115932720

PREMIA SPINE LTD

Abdominal/ENT/orthopaedic surgical probe, reusable

• Primary Device ID: 07290115932720
• NIH Device Record Key: c95c6924-39e4-4768-89e6-d5b765bdb4f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MIS Cannulated Pedicle Probe
• Version Model Number: 86047
• 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	07290115932720 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150380
• Premarket Approval: P220002

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System
• QWK: Prosthesis, Posterior Spinal Elements

Sterilization

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

[07290115932720]

Moist Heat or Steam Sterilization

[07290115932720]

Moist Heat or Steam Sterilization

[07290115932720]

Moist Heat or Steam Sterilization

[07290115932720]

Moist Heat or Steam Sterilization

[07290115932720]

Moist Heat or Steam Sterilization

[07290115932720]

Moist Heat or Steam Sterilization

[07290115932720]

Moist Heat or Steam Sterilization

[07290115932720]

Moist Heat or Steam Sterilization

[07290115932720]

Moist Heat or Steam Sterilization

[07290115932720]

Moist Heat or Steam Sterilization

[07290115932720]

Moist Heat or Steam Sterilization

[07290115932720]

Moist Heat or Steam Sterilization

[07290115932720]

Moist Heat or Steam Sterilization

[07290115932720]

Moist Heat or Steam Sterilization

[07290115932720]

Moist Heat or Steam Sterilization

[07290115932720]

Moist Heat or Steam Sterilization

[07290115932720]

Moist Heat or Steam Sterilization

[07290115932720]

Moist Heat or Steam Sterilization

[07290115932720]

Moist Heat or Steam Sterilization

[07290115932720]

Moist Heat or Steam Sterilization

[07290115932720]

Moist Heat or Steam Sterilization

[07290115932720]

Moist Heat or Steam Sterilization

[07290115932720]

Moist Heat or Steam Sterilization

[07290115932720]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-11
• Device Publish Date: 2024-09-03

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• 07290014381186 - SST 316 LVM, Blunt-Sharp Tip, L=470, Ø1.7 Awl-Shidi (Marked): 2025-09-16
• 07290014381193 - SST 316 LVM, Blunt-Threaded Tip, L=470, Ø1.7 over the K-Wire: 2025-09-16
• 07290014381209 - SST 316 LVM, Blunt-Sharp Tip, Blunt- Sharp Tip, L=470, Ø1.5 over the K-Wire: 2025-09-16